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Richard Wolf GmbH · Model 89141 · UDI-DI 04055207008393

KNS HIF FJL GCM

510(k) clearances

17,476

Adverse events (81 deaths)

125

Recalls

118

Facilities

Description

SEALING CAP CAP 4-6MM large for instruments with diameter 4 to 6 mm, colour: red

Recalls

Date	Firm	Reason
2026-08-19	Olympus Corporation of the Americas	Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
2026-08-19	Olympus Corporation of the Americas	Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
2026-08-19	Olympus Corporation of the Americas	Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
2026-08-19	Olympus Corporation of the Americas	Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.

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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.