Data Foundry

Medical device recalls 2026

Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN… — Class II medical device recall Z-2788-2026

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-2788-2026
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
Quantity155 kits
UPC / GTIN / UDI-DI10198459213342, 10198459346873, 40198459213343, 40198459346874
Lot numbers25ABM761, 25BBD107, 25FBD534, 25FBL772, 25FBR237

Product

Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART MOSES, Medline Kit SKU DYNJ910103B; 2) BASIC HEART CDS, Medline Kit SKU DYNJ910961A.

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-2788-2026. 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.