RecallRadar

FDA Device recall Z-2593-2025

Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B

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

AgencyFDA Device
Recall numberZ-2593-2025
ClassificationClass I
Statusongoing
Initiated2025-08-08
Published2025-10-08
Last updated2026-09-13 11:57 UTC
CompanyMedline Industries
DistributionFL, 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_info1) 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

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.