Olympus HALO PKS Cutting Forceps Class II Recall - Jaw Break Risk
Summary
Olympus is recalling HALO PKS Cutting Forceps (Model HACF0533) due to supplier weld validation deficiencies causing potential jaw breakage during clinical procedures. The recall affects products distributed worldwide including US, EU, Canada, Mexico, Australia, China, Singapore, Korea, and Japan. Healthcare providers should stop using affected devices and contact the recalling firm.
What changed
Olympus is recalling HALO PKS Cutting Forceps (Model HACF0533) due to inadequate weld validation by the supplier on device components. The defective welds can cause the forceps' jaw to break during clinical use, posing a serious patient safety risk.
Healthcare providers and medical facilities with affected products should immediately stop using them and contact the recalling firm for proper disposition. Manufacturers should review their supply chain weld validation processes to ensure compliance with quality standards. The Class II recall designation indicates potential temporary or reversible health consequences.
What to do next
- Stop using affected HALO PKS Cutting Forceps (Model HACF0533)
- Contact Olympus for recall procedures and product return
- Report adverse events to FDA MedWatch
Archived snapshot
Apr 11, 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-1641-2026 · 20260401 · Ongoing
Product
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 ...
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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