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Retractor

SAPI MED SPA · Model A.4082 · UDI-DI 08033638800102

FER Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Basile's conical anal retractor

Recalls

Date	Firm	Reason
2018-12-12	Applied Medical Resources Corp	Unintentional shifting of the tip insulation of the firm's electrosurgical probes.

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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.