Olmypus A37004ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Sheath, 10 Fr, for resectoscope · Class 2
All models of Olmypus (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- Nov 11, 2025Open, Classified
Complaints of the ceramic tip of the resection sheath breaking have been received.
Z-1454-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other Endoscope, Ac-Powered And Accessories devices
- Olympus WA22810AOLYMPUS Winter & Ibe GmbH · Endoscope, Ac-Powered And Accessories2 recalls8 reports
- Olympus A22201DOLYMPUS Winter & Ibe GmbH · Endoscope, Ac-Powered And Accessories1 recall7 reports
- Olympus A22205DOLYMPUS Winter & Ibe GmbH · Endoscope, Ac-Powered And Accessories1 recall5 reports
- Olympus A22221COLYMPUS Winter & Ibe GmbH · Endoscope, Ac-Powered And Accessories1 recall1 report
- Olympus A22257COLYMPUS Winter & Ibe GmbH · Endoscope, Ac-Powered And Accessories1 recall1 report
- Olympus A22207COLYMPUS Winter & Ibe GmbH · Endoscope, Ac-Powered And Accessories1 recall1 report
- Olympus A22203COLYMPUS Winter & Ibe GmbH · Endoscope, Ac-Powered And Accessories1 recall0 reports
- Olympus A22223COLYMPUS Winter & Ibe GmbH · Endoscope, Ac-Powered And Accessories1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page