Medline Kits containing B — Class II medical device recall Z-1050-2026
Ongoing recall by Medline Industries, LP, reported 2026-01-21, distributed nationwide. Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to c
| Recall number | Z-1050-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2025-11-26 |
| Classified | 2026-01-12 |
| Reported by FDA | 2026-01-21 |
| Distributed | Nationwide (US) |
| Quantity | 633 units |
| UPC / GTIN / UDI-DI | 10193489432794, 10193489468243, 10193489571875, 10195327461294, 10195327482893, 10198459258848, 10198459316593, 10198459418143, 10889942695911, 40193489432795, 40193489468244, 40193489571876, 40195327461295, 40195327482894, 40198459258849, 40198459316594, 40198459418144, 40889942695912 |
| Lot numbers | 25GBY100, 25HBI736, 25HBL296, 25HBN030, 25HLA445, 25HMA140, 25IBI197, 25IBL774, 25IMG620, 25IMH657, 25IMH924, 25JBH529, 25JBO555, 25JLA937, 25KBB119, 25KBH512 |
Product
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) OPEN HEART ACCESSORY CDSKit SKU CDS984289O; 2) OPEN HEART CDSKit SKU CDS984355K; 3) BAG A OPEN HEART KITKit SKU DYKM1025D; 4) RR-CABG SUPPLEMENTAL PACKKit SKU DYNJ0394752O; 5) OPEN HEART CDSKit SKU DYNJ902879T; 6) BASIC CARDIAC ANESTHESIAKit SKU DYNJ903523F; 7) OPEN HEART CDSKit SKU DYNJ905557B; 8) AN03 HEART/ANESTHESIA KIT-LFKit SKU PHS972012D.
Reason for recall
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
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-1050-2026. 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.