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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: ESG PK Cutting Forceps Recalled Due to Potential Jaw Fracture

Agency Publication Date: February 20, 2024
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Summary

Olympus Corporation of the Americas is recalling 11,123 units of the ESG PK Cutting Forceps, a surgical device used in medical procedures. The jaw of the forceps can break or fracture either during the pre-procedure inspection or during an actual medical procedure. If this occurs, it may lead to procedural delays or complications for the patient. Consumers and healthcare providers should check their inventory for affected lot numbers of model PK-CF0533.

Risk

The forceps jaw may fracture or break during use, which can lead to device failure during a surgical procedure or the potential for fragments to remain in a patient.

What You Should Do

  1. Locate your ESG PK Cutting Forceps (5MM, 33CM) and check for Model number PK-CF0533 and UDI DI 00821925035867.
  2. Verify if your device lot number matches any of the following: FR258486, FR261738, FR259544, FR263183, FR276278, FR279757, FR279625, FR279658, FR286369, FR287112, FR374622, FR207935, FR212413, FR212735, FR215061, FR216817, FR220525, FR222456, FR227254, FR227774, FR227781, FR232882, FR234845, FR247614, FR240430, FR246627, FR247039, FR248008, FR255679, FR248312, FR263636, FR263244, FR269280, FR269267, FR269269, FR287114, FR303799, FR297022, FR301062, PWO-308561, PWO-308562, PWO-308563, PWO-308560, PWO-308567, PWO-308566, PWO-308565, FR303864, FR313639, FR316869, FR319703, FR316872, FR327890, PWO-308972, FR335984, FR335990, FR337947, FR373912, FR401646, FR379790, or FR347006.
  3. If your device is affected, do not use it for medical procedures and contact your healthcare provider or Olympus Corporation of the Americas for further instructions regarding the return or replacement process.
  4. Contact the manufacturer, Olympus Corporation of the Americas, located at 3500 Corporate Pkwy, Center Valley, PA, 18034-8229 for detailed guidance on this recall.
  5. For additional information or questions, contact the FDA hotline at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer initiated recall notification via letter.

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

Affected Products

Product: ESG PK CUTTING FORCEPS, 5MM, 33CM
Model / REF:
PK-CF0533
Lot Numbers (60):
FR258486
FR261738
FR259544
FR263183
FR276278
FR279757
FR279625
FR279658
FR286369
FR287112
FR374622
FR207935
FR212413
FR212735
FR215061
FR216817
FR220525
FR222456
FR227254
FR227774
FR227781
FR232882
FR234845
FR247614
FR240430
FR246627
FR247039
FR248008
FR255679
FR248312
FR263636
FR263244
FR269280
FR269267
FR269269
FR287114
FR303799
FR297022
FR301062
PWO-308561
PWO-308562
PWO-308563
PWO-308560
PWO-308567
PWO-308566
PWO-308565
FR303864
FR313639
FR316869
FR319703

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93842
Status: Active
Manufacturer: Olympus Corporation of the Americas
Sold By: direct distribution; authorized distributors
Manufactured In: United States
Units Affected: 11,123 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.