Data Foundry

Medical device recalls 2025

Sterile Medline Convenience Kits: 1) MAJOR PACK L-F — Class I medical device recall Z-2592-2025

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-2592-2025
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
Quantity22 units
Reason classeslabeling, sterility
UPC / GTIN / UDI-DI10195327596316, 10198459117992, 40195327596317, 40198459117993
Lot numbers25GBC583, 25GBF720
Model numbersDYNJ0382730O, DYNJ61038B

Product

Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038B

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-2592-2025. 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.