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Sterile Sphincterotome

Micro-Tech (Nanjing) Co., Ltd. · Model DSP-30525-111111 · UDI-DI 06932503513036

KNS Prescription
1
510(k) clearances
17,476
Adverse events (81 deaths)
125
Recalls
118
Facilities

Description

Sterile Sphincterotome, lumen 3, TIP length 5, cutting wire 25, Outside diameter 2.5mm, Front end shape, no Rotation, half Insulation, no preload guidewire, Single Cutting wire

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.