# FDA recall Z-1901-2021

> **Adler MicroMed, Inc.** · Class II · device recall initiated 2021-04-23.

## 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

## Reason for recall

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

## Distribution

US distribution: FL, IL, MA, and PA.

## Key facts

- **Recall number:** Z-1901-2021
- **Recalling firm:** Adler MicroMed, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-23
- **Report date:** 2021-06-30
- **Termination date:** 2022-10-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1901-2021

## Citation

> AI Analytics. FDA recall Z-1901-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1901-2021. Source: US FDA. Licensed CC0.

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