FDA Device recall Z-2593-2025
Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B
- FDA Device
- Class I
- ongoing
- Published 2025-10-08
On 2025-10-08 the FDA classified a Class I recall of Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B by Medline Industries, citing convenience kits labeled as sterile have not gone through the sterilization process.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2593-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-08-08 |
| Published | 2025-10-08 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries |
| Distribution | FL, MD, NJ, TN |
Product
Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B
Reason
Convenience kits labeled as sterile have not gone through the sterilization process.
Identifiers
| code_info | 1) DYNJ45701B, UDI-DI: 10193489856279(each), 40193489856270(case), Lot Number: 25GBF686 |
|---|
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-2593-2025%22
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