FDA Device recall Z-1713-2025
Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K
- FDA Device
- Class II
- ongoing
- Published 2025-05-07
On 2025-05-07 the FDA classified a Class II recall of Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K by Medline Industries Northfield, citing it was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1713-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-19 |
| Published | 2025-05-07 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K
Reason
It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Identifiers
| code_info | UDI/DI 10195327385521 (EA)40195327385522 (CS), Lot Numbers: 23LME299 |
|---|
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-1713-2025%22
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