Data Foundry

Medical device recalls 2025

Sterile Medline Convenience Kits: 1) EXTREMITY PACK — Class I medical device recall Z-2593-2025

Ongoing recall by Medline Industries, LP, reported 2025-10-08, distributed in FL, MD, NJ, TN. Convenience kits labeled as sterile have not gone through the sterilization process.

Recall numberZ-2593-2025
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMedline Industries, LP, Northfield, IL, United States
Recall initiated2025-08-08
Classified2025-09-26
Reported by FDA2025-10-08
DistributedFL, MD, NJ, TN
Quantity88 units
Reason classeslabeling, sterility
UPC / GTIN / UDI-DI10193489856279, 40193489856270
Lot numbers25GBF686
Model numbersDYNJ45701B

Product

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

Reason for recall

Convenience kits labeled as sterile have not gone through the sterilization process.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2593-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.