FDA Device recall Z-1366-2025
Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. 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 MINOR PACK and LAPAROSCOPY. 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-1366-2025 |
| 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 MINOR PACK and LAPAROSCOPY. Sterile surgical drape.
Reason
Potential breach in pouch packaging which could lead to loss of sterility.
Identifiers
| code_info | Item No. DYNJ34603F & DYNJ903916I; UDI (case): 40198459143596 & 40195327580118; UDI (each): 10198459143595 & 1019532758…Item No. DYNJ34603F & DYNJ903916I; UDI (case): 40198459143596 & 40195327580118; UDI (each): 10198459143595 & 10195327580117; Lot No. (Shelf Life) 25AMD464(11/30/2029), 24JMC011(04/30/2029), 25ABA362(09/30/2025), 24KBT718(02/28/2026), 24JBE997(09/30/2025), 24IBM203(02/28/2026). |
|---|
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-1366-2025%22
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