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E-LINE
Richard Wolf GmbH · Model 8626531 · UDI-DI 04055207018071
10
510(k) clearances
275
Adverse events (1 deaths)
7
Recalls
22
Facilities
Description
CYSTOSCOPE 12° 8.0/9.8FR WL 150MM rigid, with lateral ocular lens, working channel 5Fr, atraumatic distal tip, TL 283mm, rod lens system
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-09-25 | Aizu Olympus Co., Ltd. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endo |
| 2022-04-01 | Karl Storz Endoscopy | Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. |
| 2022-04-01 | Karl Storz Endoscopy | Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. |
| 2022-04-01 | Karl Storz Endoscopy | Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. |
| 2022-04-01 | Karl Storz Endoscopy | Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. |
| 2022-04-01 | Karl Storz Endoscopy | Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. |
| 2020-04-13 | American Contract Systems | The surgical gowns were manufactured in a facility that is not registered by the FDA. |
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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.