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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87074

111 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 04, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Aomori Olympus Co., Ltd.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

111 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 111

B5-2Q BALLOON CATHETER, Model No. B5-2Q - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs.

Z-0961-2021
Recall number
Z-0961-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (global); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 03K, 04K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK

Distribution pattern

US Nationwide distribution.

device · product 2 of 111

B5-2C BALLOON CATHETER 11MM DIA 2.0; Model No. B5-2C - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs.

Z-0962-2021
Recall number
Z-0962-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (global); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK

Distribution pattern

US Nationwide distribution.

device · product 3 of 111

B7-2C BALLOON CATHETER 13mm dia 2.8; model no. B7-2C - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs.

Z-0963-2021
Recall number
Z-0963-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (global); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK

Distribution pattern

US Nationwide distribution.

device · product 4 of 111

B7-2LA BALLOON CATHETER 13MM DIA 3.2, model no. B7-2LA - Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid into the biliary or pancreatic tract.

Z-0964-2021
Recall number
Z-0964-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (global); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK

Distribution pattern

US Nationwide distribution.

device · product 5 of 111

B7-2Q BALLOON CATHETER 13MM DIA 3.2, model no. B7-2Q -Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid into the biliary or pancreatic tract.

Z-0965-2021
Recall number
Z-0965-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (global); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 06K, 07K, 08K, 98K, 99K, 9XK, 9YK, 9ZK

Distribution pattern

US Nationwide distribution.

device · product 6 of 111

B-V233P-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V233P-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct stones.

Z-0966-2021
Recall number
Z-0966-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (global); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

02V, 03V, 04V, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 7 of 111

B-V243Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V243Q-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct stones.

Z-0967-2021
Recall number
Z-0967-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (global); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

03V, 04V, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 8 of 111

B-V443Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V443Q-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct stones.

Z-0968-2021
Recall number
Z-0968-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (global); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 9 of 111

PR-V614M 2-LUMEN CANNULA, model no. PR-V614M - Product Usage: Used with endoscopes to inject contrast medium in the biliary or pancreatic duct.

Z-0969-2021
Recall number
Z-0969-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (global); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK

Distribution pattern

US Nationwide distribution.

device · product 10 of 111

K-201 GUIDE SHEATH Kit 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

Z-0970-2021
Recall number
Z-0970-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (global); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 9ZK

Distribution pattern

US Nationwide distribution.

device · product 11 of 111

K-202 GUIDE SHEATH Kit 2.0MM, model no. K-202 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

Z-0971-2021
Recall number
Z-0971-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (global); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 9ZK

Distribution pattern

US Nationwide distribution.

device · product 12 of 111

K-203 GUIDE SHEATH Kit 2.6MM, model no. K-203 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

Z-0972-2021
Recall number
Z-0972-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (global); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 9ZK

Distribution pattern

US Nationwide distribution.

device · product 13 of 111

K-204 GUIDE SHEATH Kit 2.6MM, model no K-204 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

Z-0973-2021
Recall number
Z-0973-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (global); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K,02K,03K,04K,05K,06K,07K,08K,09K,95K,96K,97K,98K,99K,9XK,9YK,9ZK

Distribution pattern

US Nationwide distribution.

device · product 14 of 111

KD-611L ELECTROSURGICAL KNIFE, model no. KD-611L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.

Z-0974-2021
Recall number
Z-0974-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (global); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK

Distribution pattern

US Nationwide distribution.

device · product 15 of 111

KD-612L ELECTROSURGICAL KNIFE, model no. KD-612L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.

Z-0975-2021
Recall number
Z-0975-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (global); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK

Distribution pattern

US Nationwide distribution.

device · product 16 of 111

KD-612U ELECTROSURGICAL SNARE, model no. KD-612U - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.

Z-0976-2021
Recall number
Z-0976-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (global); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK

Distribution pattern

US Nationwide distribution.

device · product 17 of 111

KD-620LR ELECTROSURGICAL SNARE, model no. KD-620LR - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.

Z-0977-2021
Recall number
Z-0977-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (global); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK

Distribution pattern

US Nationwide distribution.

device · product 18 of 111

KD-620UR ELECTROSURGICAL SNARE, model no. KD-620UR - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.

Z-0978-2021
Recall number
Z-0978-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (global); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK

Distribution pattern

US Nationwide distribution.

device · product 19 of 111

KD-640L ELECTROSURGICAL SNARE, model no. KD-640L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.

Z-0979-2021
Recall number
Z-0979-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (global); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK

Distribution pattern

US Nationwide distribution.

device · product 20 of 111

KD-650L ELECTROSURGICAL SNARE, model no. KD-650L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.

Z-0980-2021
Recall number
Z-0980-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (global); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK

Distribution pattern

US Nationwide distribution.

device · product 21 of 111

KD-650U ELECTROSURGICAL SNARE, model no. KD-650U - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.

Z-0981-2021
Recall number
Z-0981-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (global); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK

Distribution pattern

US Nationwide distribution.

device · product 22 of 111

KD-655L ELECTROSURGICAL SNARE, model no. KD-655L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.

Z-0982-2021
Recall number
Z-0982-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (global); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK

Distribution pattern

US Nationwide distribution.

device · product 23 of 111

KD-655U ELECTROSURGICAL SNARE, model no. KD-655U - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.

Z-0983-2021
Recall number
Z-0983-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (global); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK

Distribution pattern

US Nationwide distribution.

device · product 24 of 111

SD-210U-10 ELECTROSURGICAL SNARE, model no. SD-210U-10 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.

Z-0984-2021
Recall number
Z-0984-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (global); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 92K, 93K, 95K, 96K, 97K, 98K, 99K, 9XK, 97V, 98V, 99V, 9XV, 03V, 04V, 05V, 06V, 07V, 9YV

Distribution pattern

US Nationwide distribution.

device · product 25 of 111

SD-210U-15 ELECTROSURGICAL SNARE, SD-210U-15 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.

Z-0985-2021
Recall number
Z-0985-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (global); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

05K, 07K, 09K, 92K, 93K, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 97V, 98V, 99V, 9XV, 03V, 04V, 05V, 06V, 07V, 9YV

Distribution pattern

US Nationwide distribution.

device · product 26 of 111

SD-210U-25 ELECTROSURGICAL SNARE, SD-210U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.

Z-0986-2021
Recall number
Z-0986-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

03K, 04K, 05K, 07K, 08K, 09K, 0XK, 92K, 93K, 94K, 95K, 96K, 97K, 98K, 99K, 97V, 98V, 99V, 9XV, 03V, 04V, 05V, 06V, 07V

Distribution pattern

US Nationwide distribution.

device · product 27 of 111

SD-230U-20 ELECTROSURGICAL SNARE, model no. SD-230U-20 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.

Z-0987-2021
Recall number
Z-0987-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

97V, 98V, 9XV, 9YV, 03V, 04V, 05V, 06V, 07V

Distribution pattern

US Nationwide distribution.

device · product 28 of 111

SD-240U-10 ELECTROSURGICAL SNARE, model no. SD-240U-10 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.

Z-0988-2021
Recall number
Z-0988-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

97V, 99V, 9XV, 9YV, 03V, 04V, 05V, 06V, 07V

Distribution pattern

US Nationwide distribution.

device · product 29 of 111

SD-240U-15 ELECTROSURGICAL SNARE, model no. SD-240U-15 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.

Z-0989-2021
Recall number
Z-0989-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

97V, 98V, 99V, 9YV, 03V, 04V, 05V, 06V, 07V

Distribution pattern

US Nationwide distribution.

device · product 30 of 111

SD-240U-25 ELECTROSURGICAL SNARE, model no. SD-240U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.

Z-0990-2021
Recall number
Z-0990-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

97V, 98V, 99V, 9XV, 03V, 04V, 05V, 06V, 07V

Distribution pattern

US Nationwide distribution.

device · product 31 of 111

SD-400U-10 SNAREMASTER PLUS Hot/Cold 10m, model no. SD-400U-10 - Product Usage: Used with endoscopes for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract.

Z-0991-2021
Recall number
Z-0991-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

97V, 98V, 9XV, 9YV, 03V, 05V, 06V

Distribution pattern

US Nationwide distribution.

device · product 32 of 111

SD-400U-15 SNAREMASTER PLUS Hot/Cold 15m, model no. SD-400U-15 - Product Usage: Used with endoscopes for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract.

Z-0992-2021
Recall number
Z-0992-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

97V, 98V, 03V, 04V, 06V

Distribution pattern

US Nationwide distribution.

device · product 33 of 111

INJECTOR FORCEMAX UP 2.8MMCH 21G 4MM, model no. NM-400L-0421 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-0993-2021
Recall number
Z-0993-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 34 of 111

INJECTOR FORCEMAX UP 2.8MMCH 23G 4MM, model no. NM-400L-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-0994-2021
Recall number
Z-0994-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 35 of 111

INJECTOR FORCEMAX UP 2.8MMCH 25G 4MM, model no. NM-400L-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-0995-2021
Recall number
Z-0995-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 05K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 36 of 111

INJECTOR FORCEMAX UP 2.8MMCH 23G 5MM, model no. NM-400L-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-0996-2021
Recall number
Z-0996-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 05K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 37 of 111

INJECTOR FORCEMAX UP 2.8MMCH 25G 5MM, model no. NM-400L-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-0997-2021
Recall number
Z-0997-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 04K, 05K, 07K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 38 of 111

INJECTOR FORCEMAX UP 2.8MMCH 21G 6MM, model no. NM-400L-0621 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-0998-2021
Recall number
Z-0998-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 39 of 111

INJECTOR FORCEMAX UP 2.8MMCH 23G 6MM, model no. NM-400L-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-0999-2021
Recall number
Z-0999-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 05K, 07K, 08K, 09K, 99K, 9XK, 9YK, 9ZK,

Distribution pattern

US Nationwide distribution.

device · product 40 of 111

INJECTOR FORCEMAX UP 2.8MMCH 25G 6MM, model no. NM-400L-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-1000-2021
Recall number
Z-1000-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 04K, 05K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 41 of 111

INJECTOR FORCEMAX LOWER 23G 3MM, model no. NM-400U-0323 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-1001-2021
Recall number
Z-1001-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 42 of 111

INJECTOR FORCEMAX LOWER 23G 4MM, model no. NM-400U-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-1002-2021
Recall number
Z-1002-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 43 of 111

INJECTOR FORCEMAX LOWER 25G 2.5MM, model no. NM-400U-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-1003-2021
Recall number
Z-1003-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 44 of 111

INJECTOR FORCEMAX LOWER 23G 5MM, model no. NM-400U-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-1004-2021
Recall number
Z-1004-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 45 of 111

INJECTOR FORCEMAX LOWER 25G 5MM, model no. NM-400U-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-1005-2021
Recall number
Z-1005-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 46 of 111

INJECTOR FORCEMAX LOWER 23G 6MM, model no. NM-400U-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-1006-2021
Recall number
Z-1006-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 47 of 111

INJECTOR FORCEMAX LOWER 25G 6MM, model no. NM-400U-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-1007-2021
Recall number
Z-1007-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 48 of 111

INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-400Y-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-1008-2021
Recall number
Z-1008-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, O5V, 06V, O7V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 49 of 111

INJECTOR FORCEMAX UP 2.8MMCH 21G 4MM, model no. NM-400L-0421 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-1009-2021
Recall number
Z-1009-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

03K, 04K, 05K, 06K, 98K, 99K, 9XK, 9YK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 50 of 111

INJECTOR FORCEMAX UP 2.8MMCH 21G 6MM, model no. NM-400L-0621 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-1010-2021
Recall number
Z-1010-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 51 of 111

INJECTOR FORCEMAX UP 2.8MMCH 23G 5MM, model no. NM-400L-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-1011-2021
Recall number
Z-1011-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 52 of 111

INJECTOR FORCEMAX UP 2.8MMCH 23G 6MM, model no. NM-400L-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-1012-2021
Recall number
Z-1012-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 05K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 53 of 111

INJECTOR FORCEMAX UP 2.8MMCH 25G 4MM, model no. NM-400L-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-1013-2021
Recall number
Z-1013-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 05K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 54 of 111

INJECTOR FORCEMAX UP 2.8MMCH 25G 5MM, model no. NM-400L-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-1014-2021
Recall number
Z-1014-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 04K, 05K, 07K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 55 of 111

INJECTOR FORCEMAX UP 2.8MMCH 25G 6MM, model no. NM-400L-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-1015-2021
Recall number
Z-1015-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K ,04K, 05K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 56 of 111

INJECTOR FORCEMAX LOWER 23G 3MM, model no. NM-400U-0323 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-1016-2021
Recall number
Z-1016-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 57 of 111

INJECTOR FORCEMAX LOWER 23G 4MM, model no. NM-400U-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-1017-2021
Recall number
Z-1017-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 58 of 111

INJECTOR FORCEMAX 25G 2.5MM, model no. NM-400U-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-1018-2021
Recall number
Z-1018-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 59 of 111

INJECTOR FORCEMAX LOWER 23G 5MM, model no. NM-400U-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-1019-2021
Recall number
Z-1019-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 60 of 111

INJECTOR FORCEMAX LOWER 23G 6MM 5/BX, model no. NM-400U-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-1020-2021
Recall number
Z-1020-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K,06K, 07K,08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 61 of 111

INJECTOR FORCEMAX LOWER 25G 5MM, model no. NM-400U-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-1021-2021
Recall number
Z-1021-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 05K, 06K, 09K, 0XK, 98K, 99K, 9YK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 62 of 111

INJECTOR FORCEMAX LOWER 25G 6MM, model no. NM-400U-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-1022-2021
Recall number
Z-1022-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 05K, 06K, 09K, 98K, 9XK, 9YK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 63 of 111

INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-400Y-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-1023-2021
Recall number
Z-1023-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

03K, 04K, 05K, 07K, 0XK, 98K, 9XK, 9YK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 64 of 111

INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-401L-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-1024-2021
Recall number
Z-1024-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 65 of 111

INJECTOR FORCEMAX UP 2MM CH 25G 4MM, model no. NM-401L-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-1025-2021
Recall number
Z-1025-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 66 of 111

INJECTOR FORCEMAX UP 2MM CH 23G 3MM, model no. NM-401L-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-1026-2021
Recall number
Z-1026-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 67 of 111

INJECTOR FORCEMAX UP 2MM CH 25G 5MM, model no. NM-401L-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-1027-2021
Recall number
Z-1027-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 68 of 111

INJECTOR FORCEMAX UP 2MM CH 23G 6MM, model no. NM-401L-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-1028-2021
Recall number
Z-1028-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

02K, 03K, 04K, 06K, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 69 of 111

INJECTOR FORCEMAX UP 2MM CH 25G 6MM, model no. NM-401L-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.

Z-1029-2021
Recall number
Z-1029-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 04K, 05K, 06K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 70 of 111

NEEDLEMASTER 4MMx 21G UPPER, model no. NM-610L-0421 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

Z-1030-2021
Recall number
Z-1030-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

03K, 04K, 08K, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 71 of 111

NEEDLEMASTER 4MMx 23G UPPER, model no. NM-610L-0423 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

Z-1031-2021
Recall number
Z-1031-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 72 of 111

NEEDLEMASTER 4MMx 25G UPPER, model no. NM-610L-0425 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

Z-1032-2021
Recall number
Z-1032-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

02K, 03K, 05K, 07K, 08K, 0XK, 98K, 99K, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 73 of 111

NEEDLEMASTER 4MMx 26G UPPER, model no. NM-610L-0426 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

Z-1033-2021
Recall number
Z-1033-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 04K, 05K, 06K, 07K, 08K, 09K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 74 of 111

NEEDLEMASTER 5MMx 21G UPPER, model no. NM-610L-0521 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

Z-1034-2021
Recall number
Z-1034-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 05K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 75 of 111

NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610L-0523 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

Z-1035-2021
Recall number
Z-1035-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 98K, 99K, 9YX, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 76 of 111

NEEDLEMASTER 5MMx 25G UPPER, model no. NM-610L-0525 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

Z-1036-2021
Recall number
Z-1036-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 0XK, 98K, 99K, 9XK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 77 of 111

NEEDLEMASTER 6MMx 21G UPPER, model no. NM-610L-0621 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

Z-1037-2021
Recall number
Z-1037-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

02K, 09K, 99K, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 78 of 111

NEEDLEMASTER 6MMx 23G UPPER, model no. NM-610L-0623 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

Z-1038-2021
Recall number
Z-1038-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

05K, 06K, 07K, 08K, 09K, 0XK, 98K, 9XK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 79 of 111

NEEDLEMASTER 6MMx 25G UPPER, model no. NM-610L-0625 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

Z-1039-2021
Recall number
Z-1039-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 80 of 111

NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0323 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

Z-1040-2021
Recall number
Z-1040-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 81 of 111

NEEDLEMASTER 3MMx 26G LOWER, model no. NM-610U-0326 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

Z-1041-2021
Recall number
Z-1041-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 04K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 82 of 111

NEEDLEMASTER 4MMx 23G LOWER, model no. NM-610U-0423 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

Z-1042-2021
Recall number
Z-1042-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 83 of 111

NEEDLEMASTER 4MMx 25G LOWER, model no. NM-610U-0425 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

Z-1043-2021
Recall number
Z-1043-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 84 of 111

NEEDLEMASTER 4MMx 26G LOWER, model no. NM-610U-0426 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

Z-1044-2021
Recall number
Z-1044-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 85 of 111

NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0523 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

Z-1045-2021
Recall number
Z-1045-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 86 of 111

NEEDLEMASTER 5MMx 25G LOWER, model no. NM-610U-0525 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

Z-1046-2021
Recall number
Z-1046-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 87 of 111

NEEDLEMASTER 6MMx 23G LOWER, model no. NM-610U-0623 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

Z-1047-2021
Recall number
Z-1047-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 88 of 111

NEEDLEMASTER 6MMx 25G LOWER, model no. NM-610U-0625 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

Z-1048-2021
Recall number
Z-1048-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 04K, 06K, 0XK, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 89 of 111

NEEDLEMASTER 1.8MMx 26G LOWER, model no. NM-610U-1826 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

Z-1049-2021
Recall number
Z-1049-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 90 of 111

K-201 GUIDE SHEATH KIT 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

Z-1050-2021
Recall number
Z-1050-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 9ZK

Distribution pattern

US Nationwide distribution.

device · product 91 of 111

K-202 GUIDE SHEATH KIT 2.0MM, model no. K-202 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

Z-1051-2021
Recall number
Z-1051-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 9ZK

Distribution pattern

US Nationwide distribution.

device · product 92 of 111

K-203 GUIDE SHEATH KIT 2.6MM, model no. K-203 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

Z-1052-2021
Recall number
Z-1052-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 9ZK

Distribution pattern

US Nationwide distribution.

device · product 93 of 111

K-204 GUIDE SHEATH KIT 2.6MM, model no. K-204 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

Z-1053-2021
Recall number
Z-1053-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 9ZK

Distribution pattern

US Nationwide distribution.

device · product 94 of 111

NA-401D-1321 ASPIRATION NEEDLE, model no. NA-401D-1321 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

Z-1054-2021
Recall number
Z-1054-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK

Distribution pattern

US Nationwide distribution.

device · product 95 of 111

NA-401D-1521 ASPIRATION NEEDLE, model no. NA-401D-1521 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

Z-1055-2021
Recall number
Z-1055-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK

Distribution pattern

US Nationwide distribution.

device · product 96 of 111

NA-411D-1321 ASPIRATION NEEDLE, model no. NA-411D-1321 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

Z-1056-2021
Recall number
Z-1056-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK

Distribution pattern

US Nationwide distribution.

device · product 97 of 111

NA-411D-1521 ASPIRATION NEEDLE, model no. NA-411D-1521 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

Z-1057-2021
Recall number
Z-1057-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK

Distribution pattern

US Nationwide distribution.

device · product 98 of 111

NA-601D-1519 ASPIRATION NEEDLE, model no. NA-601D-1519 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

Z-1058-2021
Recall number
Z-1058-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK

Distribution pattern

US Nationwide distribution.

device · product 99 of 111

NA-201SX-4021 ASPIRATION NEEDLE VIZISHOT 21G, model no. NA-201SX-4021 - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus.

Z-1059-2021
Recall number
Z-1059-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 92K, 93K, 94K, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 9ZK, 95V, 96V, 97V, 98V, 99V, 9XV, 9YV, 9ZV, 01V, 02V, 03V, 04V, 05V, 06V, 07V, 08V,09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 100 of 111

NA-201SX-4022-ASPIRATION NEEDLE VIZISHOT 22G, model no. NA-201SX-4022-A - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus.

Z-1060-2021
Recall number
Z-1060-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 92K, 93K, 94K, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 96V, 97V, 98V, 99V, 9XV, 9YV, 9ZV, 01V, 02V, 03V, 04V, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 101 of 111

NA-201SX-4022-B ASPIRATION NEEDLE ViziShot 22G, model no. NA-201SX-4022-B - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus.

Z-1061-2021
Recall number
Z-1061-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

07K, 08K, 92K, 93K, 95V, 96V, 97V, 98V, 99V, 9XV, 9YV, 9ZV, 01V, 02V, 03V, 04V, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 102 of 111

NA-201SX-4022-C ASPIRATION NEEDLE ViziShot 22G w/o stylet, model no. NA-201SX-4022-C - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus.

Z-1062-2021
Recall number
Z-1062-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

03K, 04K, 95V, 96V, 97V, 98V, 99V, 9XV, 9YV, 9ZV, 01V, 02V, 03V, 04V, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution pattern

US Nationwide distribution.

device · product 103 of 111

PBD-203-0703 BILIARY STENT, model no. PBD-203-0703 - Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.

Z-1063-2021
Recall number
Z-1063-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

97K

Distribution pattern

US Nationwide distribution.

device · product 104 of 111

PBD-203-0704 BILIARY STENT, model no. PBD-203-0704 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.

Z-1064-2021
Recall number
Z-1064-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

04K

Distribution pattern

US Nationwide distribution.

device · product 105 of 111

PBD-203-0707 BILIARY STENT, model no. PBD-203-0707 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.

Z-1065-2021
Recall number
Z-1065-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

95K, 96K, 97K, 98K, 99K

Distribution pattern

US Nationwide distribution.

device · product 106 of 111

PBD-203-0710 BILIARY STENT, model no. PBD-203-0710 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.

Z-1066-2021
Recall number
Z-1066-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K

Distribution pattern

US Nationwide distribution.

device · product 107 of 111

MAJ-244 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-244 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.

Z-1067-2021
Recall number
Z-1067-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 04K, 05K, 06K, 07K, 09K, 92K, 93K, 94K, 95K, 97K, 9XK

Distribution pattern

US Nationwide distribution.

device · product 108 of 111

MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-247 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.

Z-1068-2021
Recall number
Z-1068-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 92K, 93K, 94K, 97K, 98K, 99K, 9XK, 9YK, 9ZK

Distribution pattern

US Nationwide distribution.

device · product 109 of 111

NA-200H-8022 22G EZSHOT ASPIRATION NEEDLE, model no. NA-200H-8022 - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the gastrointestinal tract.

Z-1069-2021
Recall number
Z-1069-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 06K, 92K, 93K, 94K, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 9ZK

Distribution pattern

US Nationwide distribution.

device · product 110 of 111

CRESCENT SNARE, model no. SD-221L-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.

Z-1070-2021
Recall number
Z-1070-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 07K, 08K, 09K, 0XK, 93K, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 9ZK

Distribution pattern

US Nationwide distribution.

device · product 111 of 111

CRESCENT SNARE, model no. SD-221U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.

Z-1071-2021
Recall number
Z-1071-2021
Initiated
January 04, 2021
Classification
Class II
Status
Terminated
Recalling firm
Aomori Olympus Co., Ltd.
Quantity
7,400,000 (globally); 260,395 (US)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
inadequate package
Sterility assurance reason.sterility_assurance · v1.0.0
sterile packages with inadequate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Code information

01K, 02K, 03K, 04K, 05K, 07K, 08K, 09K, 0XK, 92K, 93K, 94K, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 9ZK

Distribution pattern

US Nationwide distribution.

Field note

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