Recall Z-2593-2025 ยท OJH Orthopedic Tray
Medline Industries, LP
Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B
| Date | Sep 26, 2025 (initiated Aug 8, 2025) |
| Status | Open, Classified |
| Reason | Convenience kits labeled as sterile have not gone through the sterilization process. |
| Root cause | Process control |
| Action | Customers were alerted via email and telephone beginning 8/8/25 of a potential issue with the products. An URGENT MEDICAL DEVICE RECALL notification letter dated 8/22/25 was sent to customers. This communication is a follow-up to the notification you received from your Medline Sales Representative and to acknowledge the subsequent return of impacted product to Medline. This communication is to provide formal documentation of the recall for your records. No additional action is required to be taken. Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Sterile Medlin |
| Quantity | 88 units |
| Distribution | US Distribution to States of: FL, MD, NJ, TN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.