Recall Z-3210-2026 ยท OJK Eye Tray
Medline Industries, LP
Convenience kits CATARACT PACK DYNJ59881A
| Date | Sep 16, 2026 (initiated Jul 31, 2026) |
| Status | Open, Classified |
| Reason | Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used. |
| Root cause | Under Investigation by firm |
| Action | Firm began notifying customers on July 31, 2026 via email and first-class mail. Customers were instructed to discard any affected sterile convenience kits. |
| Quantity | 336 |
| Distribution | US Nationwide distribution in states of Arkansas, Florida, North Carolina, Maryland, and Texas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.