Device recall
Z-1901-2021: Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product…
FDA device recall · Class II · Adler MicroMed, Inc.
Key facts
| Recall number (Z-number) | Z-1901-2021 |
|---|---|
| Recall event | 87812 |
| 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… |
| Product code | KDM |
| Recalling firm | Adler MicroMed, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 4, 2022 |
| 510(k) numbers | K070913, K070915 |
| FEI number | 3011412640 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database