Proxima Drape labeled as MINOR PACK and LAPAROSCOPY — Class II medical device recall Z-1366-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-03-26, distributed nationwide. Potential breach in pouch packaging which could lead to loss of sterility.
| Recall number | Z-1366-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2025-02-13 |
| Classified | 2025-03-14 |
| Reported by FDA | 2025-03-26 |
| Distributed | Nationwide (US) |
| Quantity | 506 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10195327580117, 10198459143595, 40195327580118, 40198459143596 |
| Model numbers | DYNJ34603F, DYNJ903916I |
Product
Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.
Reason for recall
Potential breach in pouch packaging which could lead to loss of sterility.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1366-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.