Olympus PKS Cutting Forceps Recall - Jaw May Break
Summary
FDA announced a Class II recall of Olympus PKS Cutting Forceps (Model 920000PK) due to defective welds. The supplier failed to adequately validate the welding process for components, potentially causing the forceps' jaw to break during clinical use. The recall affects units distributed worldwide including the US, Canada, Mexico, EU, Australia, China, Singapore, Korea, and Japan.
What changed
FDA issued a Class II device recall for Olympus PKS Cutting Forceps (Model 920000PK, 5mm 24cm with cord) after identifying that the supplier inadequately validated the welding process for device components. Defective welds can cause the forceps' jaw to break during surgical procedures, posing patient safety risks.
Healthcare providers, hospitals, and surgical centers using these cutting forceps should immediately identify affected units, discontinue clinical use, and coordinate with Olympus for return or replacement. The recall applies to all units distributed across US and international markets including Canada, Mexico, EU, Australia, China, Singapore, Korea, and Japan.
What to do next
- Identify all Olympus PKS Cutting Forceps Model 920000PK in inventory
- Cease use of affected devices immediately
- Contact Olympus Corporation for return/replacement instructions
Archived snapshot
Apr 10, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Olympus Corporation of the Americas
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1643-2026 · 20260401 · Ongoing
Product
Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920000PK Product Description: The PKS Cutting Forceps are intended to be passed t...
Reason for Recall
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Distribution
Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan.
Source: openFDA Enforcement API
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