FDA Device recall Z-1901-2021
Sapi Med sterile disposable colorectal anoscopes and proctoscopes
- FDA Device
- Class II
- terminated
- Published 2021-06-30
On 2021-06-30 the FDA classified a Class II recall of Sapi Med sterile disposable colorectal anoscopes and proctoscopes by Adler Micromed, citing due to issue with product sterility. Sterilization service provider had falsified records.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1901-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-23 |
| Published | 2021-06-30 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Adler Micromed |
| Distribution | FL, IL, MA, PA |
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
Due to issue with product sterility. Sterilization service provider had falsified records.
Identifiers
| code_info | REF Numbers/Lot Numbers: REF A.4083 /Lot Numbers: 18D004l, 19C010l, 19l018l, 20l027l; REF A.4084/Lot Number: 19l015l;…REF Numbers/Lot Numbers: REF A.4083 /Lot Numbers: 18D004l, 19C010l, 19l018l, 20l027l; REF A.4084/Lot Number: 19l015l; REF A.4519/Lot Numbers: 18l013l, 18l012l, 19D002l, 19F012l; REF A.4522/Lot Numbers: 18G003l, 19K023l; REF A.4086/Lot Number: 18F027l; Sterilization Batch Numbers: 18042311; 18092611; 18071211_1; 19040512; 18073112; 19092713; 19120612; 19063012; 20102212; 19063012; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1901-2021%22
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