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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Olympus Corporation of the Americas: Everest Bipolar Cutting Forceps Recalled for Sterile Packaging Breaches

Agency Publication Date: August 8, 2024
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Summary

Olympus Corporation of the Americas is recalling approximately 11,449 units of Everest Bipolar Cutting Forceps due to fractures and breakages discovered in the packaging trays and Tyvek covers. These surgical instruments are used in medical procedures for grasping and cutting tissue, and any damage to the packaging can lead to a sterility breach. If the sterile barrier is broken, the device can become contaminated, posing a significant infection risk to patients. Consumers should contact their healthcare provider or the manufacturer for further instructions regarding this voluntary recall.

Risk

Cracks or holes in the packaging tray or Tyvek lid can expose the surgical forceps to environmental contaminants and bacteria before use. This loss of sterility can cause serious infections or complications in patients undergoing surgical procedures.

What You Should Do

  1. Identify if you have the affected Everest Bipolar Cutting Forceps by checking the product packaging for Recall Numbers Z-2540-2024, Z-2541-2024, or Z-2542-2024.
  2. Check the batch numbers on your device packaging. Affected batches for product Z-2540-2024 include: FR150448, FR154445, and FR173022.
  3. For product Z-2541-2024, check for UDI 00821925035881 and batch numbers including 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, or PW308683.
  4. For product Z-2542-2024, check for UDI 00821925035898 and batch numbers including 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, or PW308723.
  5. If you have an affected device, do not use it and contact your healthcare provider or Olympus Corporation of the Americas for further instructions and information on a potential refund or replacement.
  6. For additional information, contact the FDA hotline at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Everest Bipolar Cutting Forceps (Z-2540-2024)
Model / REF:
Z-2540-2024
Lot Numbers:
FR150448
FR154445
FR173022
Product: Everest Bipolar Cutting Forceps (Z-2541-2024)
Model / REF:
Z-2541-2024
UPC Codes:
00821925035881
Lot Numbers:
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
Product: Everest Bipolar Cutting Forceps (Z-2542-2024)
Model / REF:
Z-2542-2024
UPC Codes:
00821925035898
Lot Numbers:
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

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94953
Status: Active
Manufacturer: Olympus Corporation of the Americas
Sold By: Authorized Medical Distributors
Manufactured In: United States
Units Affected: 3 products (100 unirs; 6985 units; 4364 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.