FDA Device recall Z-1365-2025
Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape
- FDA Device
- Class II
- ongoing
- Published 2025-03-26
On 2025-03-26 the FDA classified a Class II recall of Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape by Medline Industries Northfield, citing potential breach in pouch packaging which could lead to loss of sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1365-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-13 |
| Published | 2025-03-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.
Reason
Potential breach in pouch packaging which could lead to loss of sterility.
Identifiers
| code_info | Item No. DYNJ84258A & DYNJ84258B; UDI (case): 40195327650743 & 40198459117986; UDI (each): 10195327650742 & 10198459117…Item No. DYNJ84258A & DYNJ84258B; UDI (case): 40195327650743 & 40198459117986; UDI (each): 10195327650742 & 10198459117985; Lot No. (Shelf Life) 24HBK264 (12/31/26) & 24IBD271 (7/31/26). . |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1365-2025%22
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