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SHARK
Richard Wolf GmbH · Model 8676326 · UDI-DI 04055207019696
10
510(k) clearances
940
Adverse events (5 deaths)
33
Recalls
40
Facilities
Description
SHEATH RESECTOSCOPE 26FR color code black, SL 201 mm, round, rotatable, slanted distal end, ceramic, intermittent flushing, compatible with Shark irrigation adaptor 8676354 or 8676361, and telescopes Ø 4 mm, 0°/12°/30°, Snap-On lock, reusable
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-11 | Olympus Corporation of the Americas | Complaints of the ceramic tip of the resection sheath breaking have been received. |
| 2025-11-11 | Olympus Corporation of the Americas | Complaints of the ceramic tip of the resection sheath breaking have been received. |
| 2025-11-11 | Olympus Corporation of the Americas | Complaints of the ceramic tip of the resection sheath breaking have been received. |
| 2025-11-11 | Olympus Corporation of the Americas | Complaints of the ceramic tip of the resection sheath breaking have been received. |
| 2025-11-11 | Olympus Corporation of the Americas | Complaints of the ceramic tip of the resection sheath breaking have been received. |
| 2025-11-11 | Olympus Corporation of the Americas | Complaints of the ceramic tip of the resection sheath breaking have been received. |
| 2025-11-11 | Olympus Corporation of the Americas | Complaints of the ceramic tip of the resection sheath breaking have been received. |
| 2025-11-11 | Olympus Corporation of the Americas | Complaints of the ceramic tip of the resection sheath breaking have been received. |
| 2025-11-11 | Olympus Corporation of the Americas | Complaints of the ceramic tip of the resection sheath breaking have been received. |
| 2025-11-11 | Olympus Corporation of the Americas | Complaints of the ceramic tip of the resection sheath breaking have been received. |
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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.