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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94953

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

Open FDA event record

Event summary

Timeline bucket
July 01, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Olympus Corporation of the Americas

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

3 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 3

The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical energy under visualization. The device is to be used with bipolar outputs of compatible generators. The forceps' jaws are electrically isolated from each other enabling one jaw to act as a return electrode, eliminating the need for a return pad. To transect tissue, a cutting blade is actuated and moves between the electrode jaws. The connections (bipolar electrical signal) to the forceps are through either a hardwired cable (model 3006) or a connector at the bottom of the handle (models 3000 and 3005). The device includes mechanisms (switches and triggers) to provide coagulation using the bipolar electrical energy that reaches the forceps. The forceps are positioned in the desired location for grasping, coagulation, and transection of tissue. The anatomical structure to be coagulated is placed between the open forceps jaws, and once the Forceps Grip trigger is squeezed, the forceps' jaws are closed onto tissue, followed by coagulation. The device includes a blade that is mechanically advanced to perform tissue cutting as needed.

Z-2540-2024
Recall number
Z-2540-2024
Initiated
July 01, 2024
Classification
Class II
Status
Ongoing
Quantity
100 unirs

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach

Code information

UDI: N/A Batch Numbers: FR150448 FR154445 FR173022

Distribution pattern

Worldwide distribution - US Nationwide and the countries of CA, DE, AU, SG, KR.

device · product 2 of 3

The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical energy under visualization. The device is to be used with bipolar outputs of compatible generators. The forceps' jaws are electrically isolated from each other enabling one jaw to act as a return electrode, eliminating the need for a return pad. To transect tissue, a cutting blade is actuated and moves between the electrode jaws. The connections (bipolar electrical signal) to the forceps are through either a hardwired cable (model 3006) or a connector at the bottom of the handle (models 3000 and 3005). The device includes mechanisms (switches and triggers) to provide coagulation using the bipolar electrical energy that reaches the forceps. The forceps are positioned in the desired location for grasping, coagulation, and transection of tissue. The anatomical structure to be coagulated is placed between the open forceps jaws, and once the Forceps Grip trigger is squeezed, the forceps' jaws are closed onto tissue, followed by coagulation. The device includes a blade that is mechanically advanced to perform tissue cutting as needed.

Z-2541-2024
Recall number
Z-2541-2024
Initiated
July 01, 2024
Classification
Class II
Status
Ongoing
Quantity
6985 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach

Code information

UDI: 00821925035881 Batch Number: FR137723 FR139935 FR141534 FR145203 FR157420 FR165250 FR176934 FR179541 FR197926 FR204443 FR206007 FR207123 FR214689 FR215012 FR215026 FR246906 FR261731 FR297010 FR305512 FR308131 FR335638 FR335650 FR378737 FR390629 FR397748 PW308683

Distribution pattern

Worldwide distribution - US Nationwide and the countries of CA, DE, AU, SG, KR.

device · product 3 of 3

The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical energy under visualization. The device is to be used with bipolar outputs of compatible generators. The forceps' jaws are electrically isolated from each other enabling one jaw to act as a return electrode, eliminating the need for a return pad. To transect tissue, a cutting blade is actuated and moves between the electrode jaws. The connections (bipolar electrical signal) to the forceps are through either a hardwired cable (model 3006) or a connector at the bottom of the handle (models 3000 and 3005). The device includes mechanisms (switches and triggers) to provide coagulation using the bipolar electrical energy that reaches the forceps. The forceps are positioned in the desired location for grasping, coagulation, and transection of tissue. The anatomical structure to be coagulated is placed between the open forceps jaws, and once the Forceps Grip trigger is squeezed, the forceps' jaws are closed onto tissue, followed by coagulation. The device includes a blade that is mechanically advanced to perform tissue cutting as needed.

Z-2542-2024
Recall number
Z-2542-2024
Initiated
July 01, 2024
Classification
Class II
Status
Ongoing
Quantity
4364 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach

Code information

UDI: 00821925035898 Batch Number: FR145210 FR150478 FR163740 FR165213 FR177466 FR179534 FR179557 FR188129 FR200177 FR215047 FR220528 FR220979 FR224466 FR234887 FR248322 FR253501 FR255664 FR263141 FR269277 FR276180 FR287091 FR303624 FR305537 FR316877 FR378738 FR388883 PW308633 PW308686 PW308722 PW308723

Distribution pattern

Worldwide distribution - US Nationwide and the countries of CA, DE, AU, SG, KR.

Field note

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