FDA-Device2026-01-21Class IIPROCESSING DEFECT
Medline IV Administration Kits recalled for stuck check valve components
What this means
Medline kits containing B. Braun IV Administration Sets may have check valve components that can become stuck in the open or closed position. This could affect proper fluid delivery during IV administration. About 1,725 units are affected nationwide.
- Check if you have one of the recalled kits: DYKS1339B, DYKS1339C, DYKS1359B, or DYKS1534D
- Do not use the kit if the lot number matches those listed in this recall
- Contact your healthcare facility or Medline for replacement or instructions
- If already used, monitor the patient for any delivery issues and contact your healthcare provider if concerned
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
1725 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) ADMIN KIT, Medline kit SKU DYKS1339B; 2) ADMIN KIT, Medline kit SKU DYKS1339C; 3) QCASC WELCOME KIT, Medline kit SKU DYKS1359B; 4) ADMISSION KIT, Medline kit SKU DYKS1534D.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1058-2026More Medline recalls
- FDA-Device2026-09-09Medline Convenience Kits recalled for potential sterility breach in antiseptic applicators
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk
- FDA-Device2026-09-09Medline Convenience Kits recalled for sterility packaging breach risk
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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