[Recalled] 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.
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| 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 |
|---|---|
| Brand / manufacturer | Adler MicroMed, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1901-2021 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 23 April 2021 |
| EAN / barcode | 18042311 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Due to issue with product sterility. Sterilization service provider had falsified records.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.