Data Foundry

Medical device recalls 2026

Medline medical convenience kits labeled as: 1) SHOULDER PACK — Class II medical device recall Z-2789-2026

Ongoing recall by Medline Industries, LP, reported 2026-07-29, distributed in CT, FL, KS, MA, MD, MT, NY, OH…. Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL w

Recall numberZ-2789-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMedline Industries, LP, Northfield, IL, United States
Recall initiated2026-06-11
Classified2026-07-23
Reported by FDA2026-07-29
DistributedCT, FL, KS, MA, MD, MT, NY, OH, OR, VA
Quantity398 kits
UPC / GTIN / UDI-DI10198459179235, 10198459187780, 10198459377600, 40198459179236, 40198459187781, 40198459377601
Lot numbers24KBK487, 24LBF187, 25ABM992, 25CBJ129, 25DBI743, 25FBU802, 25GBE239

Product

Medline medical convenience kits labeled as: 1) SHOULDER PACK, Medline Kit SKU DYNJ39590O; 2) SHOULDER PACK, Medline Kit SKU DYNJ88566; 3) MAJOR ORTHO KIT, Medline Kit SKU DYNJ911535.

Reason for recall

Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.

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-2789-2026. 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.