FDA-Device2026-03-04Class IIPROCESSING DEFECT
Olympus Resection Sheath 8mm recalled for ceramic tip fracture risk
What this means
The ceramic tip on Olympus Resection Sheath Model A42011A (8 mm) can break during use. This gynecological surgical instrument is used in medical procedures, and a broken tip could create complications. No injuries have been reported, but the FDA is recalling all units as a precaution.
- If you have this device, stop using it immediately
- Contact your healthcare facility or Olympus to return the recalled sheath
- Check the model number A42011A and UDI 04042761023658 on your device to confirm it is affected
The agency's original wording
Hazard
Complaints of the ceramic tip of the resection sheath breaking have been received.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide Distribution.
Affected count
899 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1448-2026More Olympus recalls
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