FDA Device recall Z-1394-2025
Medline procedure kits labeled as: 1) EYE PACK, Pack Number VAL038BSCLC
- FDA Device
- Class II
- ongoing
- Published 2025-03-26
On 2025-03-26 the FDA classified a Class II recall of Medline procedure kits labeled as: 1) EYE PACK, Pack Number VAL038BSCLC by Medline Industries Northfield, citing medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that ma….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1394-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-11 |
| Published | 2025-03-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Medline procedure kits labeled as: 1) EYE PACK, Pack Number VAL038BSCLC
Reason
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Identifiers
| code_info | 1) 10193489244441 (each) 40195327273133 (case), Lot Number 40193489244442 |
|---|
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-1394-2025%22
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