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GREENLIGHT

Richard Wolf GmbH · Model 8632025 · UDI-DI 04055207018095

FBO

510(k) clearances

275

Adverse events (1 deaths)

Recalls

Facilities

Description

INNER SHEATH LASER THERAPY color code yellow, SL 235mm, oval, working channel for instruments up to 7Fr, slanted distal end, stainless steel, continuous irrigation, compatible with outer sheath 8632024, and telescopes Ø 4mm, 12°/30°, bayonet-cap, 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.