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Olympus
OLYMPUS Winter & Ibe GmbH · Model WA50013L · UDI-DI 04042761062091
NWB
Prescription
1
510(k) clearances
14,167
Adverse events (2 deaths)
19
Recalls
33
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-05-05 | Olympus Corporation of the Americas | Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hou |
| 2024-01-11 | Olympus Corporation of the Americas | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in tempera |
| 2024-01-11 | Olympus Corporation of the Americas | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in tempera |
| 2024-01-11 | Olympus Corporation of the Americas | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in tempera |
| 2024-01-11 | Olympus Corporation of the Americas | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in tempera |
| 2024-01-11 | Olympus Corporation of the Americas | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in tempera |
| 2024-01-11 | Olympus Corporation of the Americas | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in tempera |
| 2024-01-11 | Olympus Corporation of the Americas | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in tempera |
| 2023-10-12 | Olympus Corporation of the Americas | There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is t |
| 2023-10-12 | Olympus Corporation of the Americas | There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is t |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.