Olympus Corporation Of The Americas recalls Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3006 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the bipolar outputs of compatible generators.
Lot / code information
- Model
- 3006
- UDI
- 00821925035898
- Lot #
- All unexpired
What the firm is doing
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.
DistributionShow detailsHide
Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1639-2026
- FDA 510(k) clearance · K023492The device's official FDA premarket clearance record
- FDA device classification · GEIOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.4400The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Olympus Corporation of the AmericasSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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