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Home › FDA recalls › Medline Kits containing B. Braun IV Administration Sets and
CLASS II · ModerateFDA

Medline Industries, LP recalls Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets

📅 Nov 26, 2025 · 📍 Nationwide
Recalling company
Medline Industries, LP
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
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.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Nov 26, 2025
Reported
Jan 21, 2026
Distribution
US Nationwide distribution.
Status
Ongoing
Quantity
11173 units
Lot / codes
Medline kit SKU DYKS1378B, UDI/DI 10195327521660 (EA) 40195327521661 (CS), Lot Number 25HBB410; Medline kit SKU DYKS1448B, UDI/DI 10195327691349 (EA) 40195327691340 (CS), Lot Number 25HBE055; Medline kit SKU DYKS1163G, UDI/DI 10195327503185 (EA) 40195327503186 (CS), Lot Number 25HBF057; Medline kit SKU DYKS1487I, UDI/DI 10198459415678 (EA) 40198459415679 (CS), Lot Number 25HBI512; Medline kit SKU DYKS2056A, UDI/DI 10198459467493 (EA) 40198459467494 (CS), Lot Number 25HBK906; Medline kit SKU DYKS2074, UDI/DI 10198459399893 (EA) 40198459399894 (CS), Lot Number 25HBV987; Medline kit SKU DYKS2083, UDI/DI 10198459435126 (EA) 40198459435127 (CS), Lot Number 25HLA076; Medline kit SKU DYKS1552B, UDI/DI 10198459269523 (EA) 40198459269524 (CS), Lot Number 25HLA432; Medline kit SKU DYKS1362A, UDI/DI 10195327343163 (EA) 40195327343164 (CS), Lot Number 25HLA829; Medline kit SKU DYKS1124C, UDI/DI 10198459447877 (EA) 40198459447878 (CS), Lot Number 25HMB303; Medline kit SKU DYKS1313A, UDI/DI 10198459370595 (EA) 40198459370596 (CS), Lot Number 25HMB948; Medline kit SKU DYKS1544F, UDI/DI 10198459411700 (EA) 40198459411701 (CS), Lot Number 25HMC488; Medline kit SKU DYKS1507B, UDI/DI 10198459489372 (EA) 40198459489373 (CS), Lot Number 25HMD440; Medline kit SKU DYKS1124C, UDI/DI 10198459447877 (EA) 40198459447878 (CS), Lot Number 25HMF480; Medline kit SKU DYKS1130B, UDI/DI 10198459377129 (EA) 40198459377120 (CS), Lot Number 25IBC508; Medline kit SKU DYKS1378B, UDI/DI 1019532752166
Company location
Northfield, IL
Recall type
Voluntary: Firm initiated
Recall number
Z-1057-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1057-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.