Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Description: Recalled by Adler MicroMed, Inc. Due to Due to issue with product sterility. Sterilization service...

Date: April 23, 2021
Company: Adler MicroMed, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Adler MicroMed, Inc. directly.

Affected Products

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

Quantity: 1,858 devices

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 4 states: FL, IL, MA, PA

Affected (4 states)Not affected

About Adler MicroMed, Inc.

Adler MicroMed, Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report