Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1901-2021 — Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Description: A.4083/THE BEAK - Surgical proctoscope. Disposable & sterile. Transparent. Self light; A.4519/MPR Short - Multi Purpose Rectoscope. 190mm long. Sterile & Disposable; A.4086/EPOFLIER - Surgical kit made

U.S. FDA — Device Enforcement · United States · 2021-04-23 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1901-2021
Date of alert: 2021-04-23
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Adler MicroMed, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 18042311

Reported risk: Due to issue with product sterility. Sterilization service provider had falsified records.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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