Recall Z-1644-2026
Olympus Corporation of the Americas · initiated February 25, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.
Codes / lots: Model: 920005PK; UDI: 00821925036178; Lot Numbers: All unexpired;
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
On February 25, 2026 URGENT: MEDICAL DEVICE REMOVAL letters were sent to customers. Actions to be taken: 1. Examine inventory and quarantine any affected devices 2. Cease usage of the product with immediate effect 3. Please contact Customer Service at 1-800-848-9024, option 2, to obtain a Return Material Authorization 4. Even if you no longer have the device, Olympus requests that you acknowledge receipt of this letter through the Olymps portal 5. Please forward this notice to other users who may have the affected products if you have further distributed it.
Details
- Recall number
- Z-1644-2026
- Initiated
- February 25, 2026
- Posted by FDA
- March 25, 2026
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Quantity
- 326 units
- Distribution
- Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan.
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1638-2026 Class II | Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest…Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately… | 02/25/2026Open, Classified |
| Z-1639-2026 Class II | Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name:…Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately… | 02/25/2026Open, Classified |
| Z-1640-2026 Class II | Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps…Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately… | 02/25/2026Open, Classified |
| Z-1641-2026 Class II | Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting…Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately… | 02/25/2026Open, Classified |
| Z-1642-2026 Class II | Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps…Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately… | 02/25/2026Open, Classified |
| Z-1643-2026 Class II | Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting…Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately… | 02/25/2026Open, Classified |