Home / Recalls / Medical Devices
Adler MicroMed, Inc. recalls Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Description: A.4083/THE BEAK - Surgic
Recalled June 30, 2021 · FDA recall Z-1901-2021 · Adler MicroMed
Hazard
Due to issue with product sterility. Sterilization service provider had falsified records. · FDA Class II
Units
1,858 devices
Sold at
US distribution: FL, IL, MA, and PA.
Description
Due to issue with product sterility. Sterilization service provider had falsified records.
Product
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 of a 34,3mm wide anoscope and an opened retractor named GULL. Disposable & sterile; A.4084/THE BEAK Diagnostic- Disposable proctoscope. Transparent. Sterile & Self lighting; A.4522/ MPR - Multi Purpose Rectoscope. 220mm long. Sterile & Disposable
Manufacturer(s)
Adler MicroMed, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →