| Date Initiated by Firm | February 25, 2026 |
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| Date Posted | March 25, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1640-2026 |
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| Recall Event ID |
98454 |
| 510(K)Number | K203277 |
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| Product Classification |
Electrosurgical, cutting & coagulation & accessories - Product Code GEI
|
| Product | Brand Name: Olympus PK Cutting Forceps, 5mm 33cm
Product Name: PK Cutting Forceps
Model/Catalog Number: PK-CF0533
Product Description: An assembly of devices intended to generate and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure. |
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| Code Information |
Model: PK-CF0533;
UDI: 00821925035867;
Lot Numbers: All unexpired;
|
| FEI Number |
2429304
|
Recalling Firm/
Manufacturer |
Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
|
| For Additional Information Contact | Cynthia Ow
647-9993203 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Nonconforming Material/Component |
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| Action | 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. |
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| Quantity in Commerce | 444 units |
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| Distribution | Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = GEI
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