Changeflow GovPing Healthcare Olympus Everest Bipolar Cutting Forceps Welding...
Urgent Enforcement Amended Final

Olympus Everest Bipolar Cutting Forceps Welding Defect Recall

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Summary

Olympus Corporation of the Americas initiated a Class II recall of Everest Bipolar Cutting Forceps (Model 3005) due to inadequate supplier welding process validation. The defect can cause the forceps' jaw to break during clinical use, posing patient safety risks. Affected products were distributed worldwide including the US, Canada, Mexico, EU, Australia, China, Singapore, Korea, and Japan.

What changed

Olympus initiated a Class II medical device recall for Everest Bipolar Cutting Forceps (Model 3005) after discovering that the supplier failed to adequately validate the welding process for critical components. The defective welds can result in the forceps' jaw breaking during surgical procedures, presenting a significant patient safety hazard.

Healthcare facilities worldwide that have purchased or use these bipolar cutting forceps must immediately discontinue use, quarantine all affected inventory, and contact Olympus to arrange returns. The recall affects units distributed across the US, Canada, Mexico, EU, Australia, China, Singapore, Korea, and Japan. Facilities should verify their inventory against model number 3005 and act promptly to mitigate risk of patient injury during procedures.

What to do next

  1. Immediately identify and quarantine all Olympus Everest Bipolar Cutting Forceps Model 3005 in your facility
  2. Cease use of affected devices pending return to Olympus
  3. Contact Olympus Corporation of the Americas to arrange product return and replacement

Archived snapshot

Apr 10, 2026

GovPing 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-1638-2026 · 20260401 · Ongoing

Product

Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3005 Product Description: The OLYMPUS Everest Bipolar Cutting ...

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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Source document text, dates, docket IDs, and authority are extracted directly from Olympus.

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Last updated

Classification

Agency
Olympus
Filed
April 1st, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive

Who this affects

Applies to
Healthcare providers Medical device makers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Medical device recall Surgical instrument inspection
Geographic scope
United States US

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Product Safety

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