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SCHÖLLY FIBEROPTIC GmbH · Model 41.0674a · UDI-DI 04250480106129

FGA FEC FED Prescription

510(k) clearances

Adverse events (7 deaths)

Recalls

Facilities

Description

UMP - Water jet sheath, 13 Fr., WL: 180 mm

Recalls

Date	Firm	Reason
2024-07-23	Karl Storz Endoscopy	Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-07-23	Karl Storz Endoscopy	Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-07-23	Karl Storz Endoscopy	Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-07-23	Karl Storz Endoscopy	Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-07-23	Karl Storz Endoscopy	Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-07-23	Karl Storz Endoscopy	Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-07-23	Karl Storz Endoscopy	Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-07-23	Karl Storz Endoscopy	Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy 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.