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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90769

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

Open FDA event record

Event summary

Timeline bucket
July 29, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Hobbs Medical, Inc.

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

61 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 61

Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190

Z-0010-2023
Recall number
Z-0010-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
275 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UD-DI: M84921900 Lot Numbers: H02-18-166R H02-18-167R H02-18-168R H02-18-169R H04-18-214R H11-17-182R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 2 of 61

Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 2191

Z-0011-2023
Recall number
Z-0011-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
30 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84921910 Lot Numbers: H03-16-015R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 3 of 61

Hobbs Medical Flex-Ez Guide Wire Disposable For endoscopy procedures Ref: 3412

Z-0012-2023
Recall number
Z-0012-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
32 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UD-DI: M84934120 Lot Numbers: H05-18-091R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 4 of 61

Hobbs Medical Cytology Brush Catalog Number: 4204

Z-0013-2023
Recall number
Z-0013-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
300 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84942040 Lot Numbers: H10-19-001R H12-19-050R H12-19-051R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 5 of 61

Hobbs Medical Cytology Brush Catalog Number: 4206

Z-0014-2023
Recall number
Z-0014-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
300 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI:M84942060 Lot Numbers: H01-20-179R H01-20-181R H01-20-182R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 6 of 61

Hobbs Medical Polypectomy Snare Catalog Number: 4563

Z-0015-2023
Recall number
Z-0015-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
100 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84945630 Lot Numbers: H03-16-067R H09-15-146R H10-15-086R H12-15-100R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 7 of 61

Hobbs Medical Polypectomy Snare Catalog Number: 4564

Z-0016-2023
Recall number
Z-0016-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
35 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84945640 Lot Numbers: H02-18-198R H09-17-027R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 8 of 61

Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620

Z-0017-2023
Recall number
Z-0017-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
18 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84946200 Lot Numbers: H06-17-090R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 9 of 61

Hobbs Transbronchial Aspiration Needle Catalog Number: 4621

Z-0018-2023
Recall number
Z-0018-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
7 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI:M84946210 Lot Numbers: H04-17-039R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 10 of 61

Hobbs Scope Introducer Catalog Number: 4650

Z-0019-2023
Recall number
Z-0019-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
140 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84946500 Lot Numbers: H04-18-182R H04-18-181R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 11 of 61

Hobbs Posi-Stop Injection Needle Catalog Number: 4702

Z-0020-2023
Recall number
Z-0020-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
8 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI:M84947020 Lot Numbers: H10-17-062R H10-17-062R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 12 of 61

Hobbs Posi-Stop Injection Needle Catalog Number: 4704

Z-0021-2023
Recall number
Z-0021-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
7 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84947040 Lot Numbers: H01-17-198R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 13 of 61

Hobbs Posi-Stop Injection Needle Catalog Number: 4712

Z-0022-2023
Recall number
Z-0022-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
6 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84947120 Lot Numbers: H04-15-157R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 14 of 61

Hobbs Posi-Stop Injection Needle Catalog Number: 4718

Z-0023-2023
Recall number
Z-0023-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
30 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84947180 Lot Numbers: H11-17-176R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 15 of 61

Hobbs Posi-Stop Injection Needle Catalog Number: 4720

Z-0024-2023
Recall number
Z-0024-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
50 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI:M84947200 Lot Numbers: H03-18-152R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 16 of 61

Hobbs Posi-Stop Injection Needle Catalog Number: 4722

Z-0025-2023
Recall number
Z-0025-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
17 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI:M84947220 Lot Numbers: H06-18-046R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 17 of 61

Hobbs Helical Retrieval Basket Catalog Number: 4806

Z-0026-2023
Recall number
Z-0026-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
4 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84948060 Lot Numbers: H02-18-112R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 18 of 61

Hobbs Helical Retrieval Basket Catalog Number: 4808

Z-0027-2023
Recall number
Z-0027-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
2 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84948080 Lot Numbers: H02-18-113R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 19 of 61

Hobbs Helical Retrieval Basket Catalog Number: 4814

Z-0028-2023
Recall number
Z-0028-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
3 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84948140 Lot Numbers: H10-17-098R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 20 of 61

Hobbs Helical Retrieval Basket Catalog Number: 4816

Z-0029-2023
Recall number
Z-0029-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
10 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84948160 Lot Numbers: H03-18-168R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 21 of 61

Hobbs Helical Retrieval Basket Catalog Number: 4822

Z-0030-2023
Recall number
Z-0030-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
14 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84948220 Lot Numbers: H11-17-161R H02-17-102R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 22 of 61

Hobbs Helical Retrieval Basket Catalog Number: 4824

Z-0031-2023
Recall number
Z-0031-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
10 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84948240 Lot Numbers: H02-17-159R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 23 of 61

Hobbs Helical Retrieval Basket Catalog Number: 4830

Z-0032-2023
Recall number
Z-0032-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
7 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84948300 Lot Numbers: H10-16-021R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 24 of 61

Hobbs Helical Retrieval Basket Catalog Number: 4832

Z-0033-2023
Recall number
Z-0033-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
13 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84948320 Lot Numbers: H11-17-162R H01-17-137R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 25 of 61

Hobbs Medical Grasping Forceps Catalog Number:5004

Z-0034-2023
Recall number
Z-0034-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
3 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84950040 Lot Numbers: H01-17-090R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 26 of 61

Hobbs Medical Grasping Forceps Catalog Number: 5008

Z-0035-2023
Recall number
Z-0035-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
14 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84950080 Lot Numbers: H10-17-211R H09-17-086R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 27 of 61

Hobbs Retrieval Forceps Catalog Number: 5018

Z-0036-2023
Recall number
Z-0036-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
4 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84950180 Lot Numbers: H06-15-180R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 28 of 61

Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6001

Z-0037-2023
Recall number
Z-0037-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
3 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84960010 Lot Numbers: H01-19-234 H01-19-230

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 29 of 61

Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number:6004

Z-0038-2023
Recall number
Z-0038-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
2 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84960040 Lot Numbers: H02-19-022

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 30 of 61

Hobbs Biliary Pigtail Stent Kits (containing 6105) Catalog Number: 6023

Z-0039-2023
Recall number
Z-0039-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
3 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84960230 Lot Numbers: H02-19-019 H10-18-183

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 31 of 61

Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6024

Z-0040-2023
Recall number
Z-0040-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
3 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84960240 Lot Numbers: H02-19-023 H11-18-188

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 32 of 61

Hobbs Biliary Pigtail Stent Kits (contains 3412) Catalog Number: 6027

Z-0041-2023
Recall number
Z-0041-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
N/A

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84960270 Lot Numbers: H01-19-241

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 33 of 61

Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6028

Z-0042-2023
Recall number
Z-0042-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
3 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84960280 Lot Numbers: H02-19-021

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 34 of 61

Hobbs Biliary Pigtail Stent Kits Catalog Number: 6104

Z-0043-2023
Recall number
Z-0043-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
15 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84961040 Lot Numbers: H11-17-020R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 35 of 61

Hobbs Biliary Pigtail Stent Kits Catalog Number: 6105

Z-0044-2023
Recall number
Z-0044-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
7 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84961050 Lot Numbers: H10-17-031R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 36 of 61

Hobbs Biliary Pigtail Stent Kits Catalog Number: 6108

Z-0045-2023
Recall number
Z-0045-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
16 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI:M84961080 Lot Numbers: H02-18-254R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 37 of 61

Freeman Pancreatic Flexi-Stent Kit (containing 6352) Catalog Number: 6321

Z-0046-2023
Recall number
Z-0046-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
6 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI:M84963210 Lot Numbers: H08-18-064 H08-18-116 H08-18-194

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 38 of 61

Freeman Pancreatic Flexi-Stent Kit Catalog Number: 6351

Z-0047-2023
Recall number
Z-0047-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
8 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI:M84963510 Lot Numbers: H12-16-175R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 39 of 61

Freeman Pancreatic Flexi-Stent Kit Catalog Number: 6352

Z-0048-2023
Recall number
Z-0048-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
14 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84963520 Lot Numbers: H04-18-014R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 40 of 61

Freeman Pancreatic Flexi-Stent Kits: Single Pigtail Catalog Number: 6501

Z-0049-2023
Recall number
Z-0049-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
10 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84965010 Lot Numbers: H09-18-008

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 41 of 61

Freeman Pancreatic Flexi-Stent Kits: Single Pigtail (containing 6544) Catalog Number: 6503

Z-0050-2023
Recall number
Z-0050-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
3 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84965030 Lot Numbers: H05-20-155 H06-20-022

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 42 of 61

Freeman Pancreatic Flexi-Stent Kit (containing 6533) Catalog Number: 6507

Z-0051-2023
Recall number
Z-0051-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
4 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84965070 Lot Numbers: H08-18-075

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 43 of 61

Freeman Pancreatic Flexi-Stent Kit (containing 6566) Catalog Number: 6518

Z-0052-2023
Recall number
Z-0052-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
2 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84965180 Lot Numbers: H08-18-118 H08-18-212

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 44 of 61

Freeman Pancreatic Flexi-Stent Kit (containing 6567) Catalog Number: 6519

Z-0053-2023
Recall number
Z-0053-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
4 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84965190 Lot Numbers: H08-18-119 H08-18-191

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 45 of 61

Freeman Pancreatic Flexi-Stent Kit (containing 6568) Catalog Number: 6529

Z-0054-2023
Recall number
Z-0054-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
4 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84965290 Lot Numbers: H08-18-117 H08-18-192

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 46 of 61

Freeman Pancreatic Flexi-Stent Catalog Number: 6533

Z-0055-2023
Recall number
Z-0055-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
6 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84965330 Lot Numbers: H08-17-085R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 47 of 61

Freeman Pancreatic Flexi-Stent Catalog Number: 6534

Z-0056-2023
Recall number
Z-0056-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
10 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84965340 Lot Numbers: H11-17-025R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 48 of 61

Freeman Pancreatic Flexi-Stent Catalog Number: 6535

Z-0057-2023
Recall number
Z-0057-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
13 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84965350 Lot Numbers: H01-16-055R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 49 of 61

Freeman Pancreatic Flexi-Stent Catalog Number: 6544

Z-0058-2023
Recall number
Z-0058-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
27 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: 84965410 Lot Numbers: H01-20-254R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 50 of 61

Freeman Pancreatic Flexi-Stent Catalog Number: 6548

Z-0059-2023
Recall number
Z-0059-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
10 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84965480 Lot Numbers: H06-17-182R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 51 of 61

Freeman Pancreatic Flexi-Stent Catalog Number: 6562

Z-0060-2023
Recall number
Z-0060-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
30 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84965620 Lot Numbers: H02-18-260R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 52 of 61

Freeman Pancreatic Flexi-Stent Catalog Number: 6566

Z-0061-2023
Recall number
Z-0061-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
8 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84965660 Lot Numbers: H01-18-204R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 53 of 61

Freeman Pancreatic Flexi-Stent Catalog Number: 6567

Z-0062-2023
Recall number
Z-0062-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
6 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84965670 Lot Numbers: H02-18-262R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 54 of 61

Freeman Pancreatic Flexi-Stent Catalog Number: 6568

Z-0063-2023
Recall number
Z-0063-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
6 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84965680 Lot Numbers: H12-17-203R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 55 of 61

Freeman Pancreatic Flexi-Stent Catalog Number: 6582

Z-0064-2023
Recall number
Z-0064-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
4 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84965820 Lot Numbers: H07-16-033R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 56 of 61

Freeman Pancreatic Flexi-Stent Catalog Number: 6584

Z-0065-2023
Recall number
Z-0065-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
4 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84965840 Lot Numbers: H07-16-033R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 57 of 61

Freeman Pancreatic Flexi-Stent (contained in kit 6501) Catalog Number: 6541

Z-0066-2023
Recall number
Z-0066-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
1 unit

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84965840 Lot Numbers: H07-16-033R Kit Lot Number: H09-18-008

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 58 of 61

Hobbs Medical Polypectomy Snare Catalog Number: 7202

Z-0067-2023
Recall number
Z-0067-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
20 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M84972020 Lot Numbers: H10-17-089R H08-17-014R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 59 of 61

Hobbs Medical Polypectomy Snare Catalog Number: 4563-OLY

Z-0068-2023
Recall number
Z-0068-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
30 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M8494563OLY0 Lot Numbers: H03-18-137R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 60 of 61

Hobbs Medical Polypectomy Snare Catalog Number: 4565-OLY

Z-0069-2023
Recall number
Z-0069-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
10 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M8494565OLY0 Lot Numbers: H02-18-111R H04-18-063R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

device · product 61 of 61

Hobbs Medical Polypectomy Snare Catalog Number: 4575-OLY

Z-0070-2023
Recall number
Z-0070-2023
Initiated
July 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Hobbs Medical, Inc.
Quantity
10 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label display an incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)

Code information

UDI-DI: M8494575OLY0 Lot Numbers: H01-16-117R

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.

Field note

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