Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HACF0533 Product Description: The HALO PKS Cutting Forceps are intended to be passed through a 5 mm laparoscopic cannula. Coagulation is achieved using electrosurgical energy under laparoscopic visualization. The device is intended to be used with the Gyrus ACMI G400 Workstation only.
FDA Recall Z-1641-2026 · Posted 2026-03-25
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Recalling FirmOlympus Corporation of the Americas
Recall StatusOpen, Classified
Product CodeGEI
Date Initiated2026-02-25
Product Quantity2648 units
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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