Recall Z-0510-2026 ยท OJK Eye Tray
Medline Industries, LP
MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F.
| Date | Nov 14, 2025 (initiated Oct 3, 2025) |
| Status | Open, Classified |
| Reason | Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit open seals. |
| Root cause | Other |
| Action | Medline Industries issued an URGENT MEDICAL DEVICE RECALL notice to its consignee on 10/03/2025 via USPS first class mail and email. The notice explained the issue with the product, potential risk to the patient, and requested the following actions: "1.Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Upon completion of the below actions, please destroy affected product.2.Please use the link and the information below to complete your response form. Please list the quantity of affected |
| Quantity | 1024 units |
| Distribution | US: MO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.