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E-LINE

Richard Wolf GmbH · Model 865418 · UDI-DI 04055207010907

FJL
10
510(k) clearances
940
Adverse events (5 deaths)
33
Recalls
40
Facilities

Description

OBTURATOR RESECTOSCOPE 26FR color code black, WL 231 mm, round, rounded distal end, compatible with E-Line sheaths 8654.084, 8663.084, 8655.394, 8654.384, 8661.384, 8663.384, reusable

Recalls

DateFirmReason
2025-11-11Olympus Corporation of the AmericasComplaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11Olympus Corporation of the AmericasComplaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11Olympus Corporation of the AmericasComplaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11Olympus Corporation of the AmericasComplaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11Olympus Corporation of the AmericasComplaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11Olympus Corporation of the AmericasComplaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11Olympus Corporation of the AmericasComplaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11Olympus Corporation of the AmericasComplaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11Olympus Corporation of the AmericasComplaints of the ceramic tip of the resection sheath breaking have been received.
2025-11-11Olympus Corporation of the AmericasComplaints of the ceramic tip of the resection sheath breaking have been received.

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Data 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.