Device recall
Z-1368-2025: Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY…
FDA device recall · Class II · MEDLINE INDUSTRIES, LP - Northfield
Key facts
| Recall number (Z-number) | Z-1368-2025 |
|---|---|
| Recall event | 96401 |
| Product | Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUCH-LF, VEIN PACK. Sterile surgical drape. |
| Product code | LRO |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K213481 |
| FEI number | 1417592 |
At a glance
- 1–9 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