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Strauss Surgical

AMERICAN MEDICAL ENDOSCOPY, INC. · Model STS-LAP-305-00 · UDI-DI 00851925007892

KNSHET
10
510(k) clearances
17,476
Adverse events (81 deaths)
125
Recalls
118
Facilities

Recalls

DateFirmReason
2026-08-19Olympus Corporation of the AmericasPotential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
2026-08-19Olympus Corporation of the AmericasPotential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
2026-08-19Olympus Corporation of the AmericasPotential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
2026-08-19Olympus Corporation of the AmericasPotential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
2026-01-07Olympus Corporation of the AmericasDevices which did not undergo thermoforming could deform and lose performance.
2026-01-07Olympus Corporation of the AmericasDevices which did not undergo thermoforming could deform and lose performance.
2026-01-07Olympus Corporation of the AmericasDevices which did not undergo thermoforming could deform and lose performance.
2026-01-07Olympus Corporation of the AmericasDevices which did not undergo thermoforming could deform and lose performance.
2026-01-07Olympus Corporation of the AmericasDevices which did not undergo thermoforming could deform and lose performance.
2026-01-07Olympus Corporation of the AmericasDevices 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.