FDA recall, , Moderate risk
Olympus Cutting Forceps
The cutting forceps have defective welds that can cause the jaw to break during use.
Summary by Recall Canary from the FDA notice
What happened
Olympus Corporation of the Americas, of Center Valley, Pennsylvania, recalled its PKS Cutting Forceps, PK Cutting Forceps, Everest Bipolar Cutting Forceps, and Halo PKS Cutting Forceps because the supplier did not adequately validate the welding process for some components, which can cause the jaw to break during clinical use.
The recall began February 25, 2026, and was added to the FDA's Enforcement Report on March 25, 2026. The devices were distributed nationwide and in Canada, Mexico, EU, Australia, China, Singapore, Korea, and Japan.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match your product and all the details in one listed combination.
A UDI-DI is the device identifier printed with the barcode on the device label.
Olympus PKS Cutting Forceps, 5mm 33cm PKS Cutting Forceps
- UDI-DI
- 00821925036000
- Model/Catalog number
- 3005PK
- UDI-DI
- 00821925036178
- Model/Catalog number
- 920005PK
Olympus PKS Cutting Forceps w/Cord, 5mm 24cm PKS Cutting Forceps
- UDI-DI
- 00821925038080
- Model/Catalog number
- 920000PK
Olympus PK Cutting Forceps, 5mm 33cm PK Cutting Forceps
- UDI-DI
- 00821925035867
- Model/Catalog number
- PK-CF0533
Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Everest Bipolar Cutting Forceps
- UDI-DI
- 00821925035881
- Model/Catalog number
- 3005
Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Everest Bipolar Cutting Forceps
- UDI-DI
- 00821925035898
- Model/Catalog number
- 3006
Olympus Halo PKS Cutting Forceps, 5mm 33cm Halo PKS Cutting Forceps
- UDI-DI
- 00821925036390
- Model/Catalog number
- HACF0533
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan.
- Company
- Olympus Corporation of the AmericasCenter Valley, Pennsylvania
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98454
- Recall numbers
- Z-1638-2026 to Z-1644-2026
All recalls from Olympus Corporation of the Americas
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
