Sapi Med sterile disposable colorectal anoscopes and proctoscopes — Class II medical device recall Z-1901-2021
Terminated recall by Adler MicroMed, Inc., reported 2021-06-30, distributed in FL, IL, MA, PA. Due to issue with product sterility. Sterilization service provider had falsified records.
| Recall number | Z-1901-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Adler MicroMed, Inc., San Diego, CA, United States |
| Recall initiated | 2021-04-23 |
| Classified | 2021-06-21 |
| Reported by FDA | 2021-06-30 |
| Terminated | 2022-10-04 |
| Distributed | FL, IL, MA, PA |
| Quantity | 1,858 devices |
| Reason classes | sterility |
| Lot numbers | 18042311, 18073112, 18092611, 18D004L, 18F027L, 18G003L, 18L012L, 18L013L, 19040512, 19063012, 19092713, 19120612, 19C010L, 19D002L, 19F012L, 19K023L, 19L015L, 19L018L, 20102212, 20L027L, A.4083 |
| Model numbers | A.4083, A.4084, A.4086, A.4519, A.4522 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1901-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.