FDA-Device2026-03-04Class IIPROCESSING DEFECT
Olympus 10 Fr. endoscopic sheath recalled for ceramic tip fracture risk
OTHERNationwide distribution
Stop using Olympus Model A37004A sheaths
Olympus Corporation is recalling its 10 Fr. Model A37004A endoscopic sheath used in urological procedures because the ceramic tip can break during use. The company has received complaints about this defect. No injuries have been reported.
- Stop using affected sheaths immediately
- Check your inventory for Model No. A37004A with UDI 04042761023092
- Contact Olympus Corporation of the Americas for instructions on return or replacement
Hazard
Complaints of the ceramic tip of the resection sheath breaking have been received.
Sold states
US Nationwide Distribution.
Affected count
94 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1454-2026More 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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