FDA-Device2026-03-04Class IIPROCESSING DEFECT
Olympus Resection Sheath Model A22043T recalled for ceramic tip breakage
OTHERNationwide distribution
Stop using Olympus Resection Sheath A22043T
The ceramic tip on Olympus Resection Sheath Model A22043T (28 Fr. with Deflecting Obturator) can break during use. This device is used in urologic surgical procedures. The FDA has identified 207 affected units across the US.
- Stop using this device immediately if you have it in your facility
- Check your inventory for Model No. A22043T with UDI 04042761021012
- Contact Olympus Corporation of the Americas for instructions on return or replacement
- Review any procedures performed with this device and consult with your medical team if needed
Hazard
Complaints of the ceramic tip of the resection sheath breaking have been received.
Sold states
US Nationwide Distribution.
Affected count
207 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1446-2026More Olympus Corporation of the Americas recalls
- FDA-Device2026-04-08Olympus SOLTIVE Premium laser system recalled for defective power supply
- FDA-Device2026-04-08Olympus SOLTIVE Pro SuperPulsed Laser System recalled for power supply defect
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
- FDA-Device2026-04-01Olympus MAJ-1443 and MAJ-1444 endoscope suction valves no longer compatible with OER-Pro and OER-Elite reprocessors
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
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