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E-LINE

Richard Wolf GmbH · Model 86520245 · UDI-DI 04055207027974

FBO

510(k) clearances

275

Adverse events (1 deaths)

Recalls

Facilities

Description

SHEATH FOR CYSTOSCOPE 17.5FR color code green, SL 209mm, oval, slanted distal end, capacity for instruments up to 5Fr or 2x4Fr, compatible with attachments 8652254, 8652264, 8652.284, and telescopes Ø 4mm, with 2 flushing ports, quick-lock, reusable

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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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.