FDA Device recall Z-0510-2026
MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D
- FDA Device
- Class II
- ongoing
- Published 2025-11-26
On 2025-11-26 the FDA classified a Class II recall of MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D by Medline Industries, citing medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit open seals.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0510-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-03 |
| Published | 2025-11-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries |
| Distribution | MO |
Product
MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F.
Reason
Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit open seals.
Identifiers
| code_info | 1) REF: DYNJ37743D: UDI/DI 10193489600124 (each), 40193489600125 (case), Lot Number 25EMI333; 2) REF: DYNJ37743F: UD…1) REF: DYNJ37743D: UDI/DI 10193489600124 (each), 40193489600125 (case), Lot Number 25EMI333; 2) REF: DYNJ37743F: UDI/DI 10198459390685 (each), 40198459390686 (case), Lot Number 25GMD927. |
|---|
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-0510-2026%22
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