Device recall
Z-0028-2025: Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health…
FDA device recall · Class II · Windstone Medical Packaging, Inc.
Key facts
| Recall number (Z-number) | Z-0028-2025 |
|---|---|
| Recall event | 95306 |
| Product | Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure. |
| Product code | LRO |
| Recalling firm | Windstone Medical Packaging, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 1000125955 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1,000+ 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