Medline Kits containing B — Class II medical device recall Z-1057-2026
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-1057-2026 |
|---|---|
| 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 | 11,173 units |
| UPC / GTIN / UDI-DI | 10195327343163, 10195327387433, 10195327411213, 10195327482602, 10195327503185, 10195327521660, 10195327549343, 10195327549374, 10195327691349, 10198459011368, 10198459024320, 10198459025648, 10198459032448, 10198459078415, 10198459269523, 10198459291272, 10198459347702, 10198459370595, 10198459377129, 10198459399732, 10198459399893, 10198459411700, 10198459415678, 10198459435126, 10198459447877 and 43 more |
| Lot numbers | 25HBB410, 25HBE055, 25HBF057, 25HBI512, 25HBK906, 25HBV987, 25HLA076, 25HLA432, 25HLA829, 25HMB303, 25HMB948, 25HMC488, 25HMD440, 25HMF480, 25IBC508, 25IBI706, 25IBK720, 25IBL590, 25IBL885, 25IBQ969, 25IBU385, 25IBW167, 25ILA943, 25ILA944, 25IME692, 25JBB244, 25JBC342, 25JBE269, 25JBE865, 25JBG502, 25JBJ439, 25JBJ451, 25JBL575, 25JBO961, 25JBR391, 25JBS091, 25JBU194, 25JBU341, 25JBU577, 25JLA660 and 16 more |
Product
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) PRE OP KIT, Medline kit SKU DYKS1093B; 2) PRE OP KIT, Medline kit SKU DYKS1124C; 3) PRE OP KIT, Medline kit SKU DYKS1128C; 4) PREOP KIT, Medline kit SKU DYKS1130B; 5) PRE OP KIT, Medline kit SKU DYKS1163G; 6) PRE OP KIT SURGERY, Medline kit SKU DYKS1263G; 7) PREOP KIT, Medline kit SKU DYKS1313A; 8) PRE OP KIT, Medline kit SKU DYKS1325A; 9) ADULT PRE OP KIT, Medline kit SKU DYKS1337D; 10) PRE OP KIT ADULT, Medline kit SKU DYKS1362A; 11) PRE-OP - OUTPATIENT KIT, Medline kit SKU DYKS1378B; 12) PRE-OP INPATIENT KIT, Medline kit SKU DYKS1379B; 13) PRE OP KIT, Medline kit SKU DYKS1382A; 14) PRE OP KIT, Medline kit SKU DYKS1416F; 15) PREOP KIT, Medline kit SKU DYKS1448B; 16) PRE-OP KIT, Medline kit SKU DYKS1458F; 17) PRE OP KIT, Medline kit SKU DYKS1467B; 18) PRE OP KIT, Medline kit SKU DYKS1468; 19) PRE-OP, Medline kit SKU DYKS1482A; 20) ADULT PRE OP, Medline kit SKU DYKS1487I; 21) PRE OP ENDO, Medline kit SKU DYKS1489F; 22) PREOP KIT, Medline kit SKU DYKS1507B; 23) PRE OP KIT, Medline kit SKU DYKS1518A; 24) PRE OP KIT, Medline kit SKU DYKS1544F; 25) PREOP, Medline kit SKU DYKS1551B; 26) PREOP, Medline kit SKU DYKS1552B; 27) PREOP, Medline kit SKU DYKS1580; 28) PRE OP KIT, Medline kit SKU DYKS2024A; 29) PRE OP KIT, Medline kit SKU DYKS2056A; 30) PRE-OP KIT, Medline kit SKU DYKS2074; 31) PRE-OP KIT, Medline kit SKU DYKS2074A; 32) PREOP KIT, Medline kit SKU DYKS2076; 33) PRE OP KIT 1, Medline kit SKU DYKS2083; 34) PRE OP KIT, Medline kit SKU DYKS2103.
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-1057-2026. 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.