FDA-Device2026-01-21Class IIPROCESSING DEFECT
Medline IV Administration Kits recalled for stuck check valve components
What this means
Medline has recalled five IV starter kits that contain B. Braun IV administration sets. The check valve components in these sets may become stuck in the open or closed position, which could affect proper IV fluid delivery. No injuries have been reported so far.
- Check if you have any of the five affected Medline IV kits by SKU number (DYKM1980C, DYKM2137B, DYKS1372C, DYNDV1691B, or DYNDV2464A)
- Do not use kits matching the recalled lot numbers listed in the recall notice
- Contact Medline or your healthcare provider for a replacement or guidance
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
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
5314 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) IV START KIT NS, Medline kit SKU DYKM1980C; 2) (134) L&D IV-START SET, Medline kit SKU DYKM2137B; 3) IV START KIT, Medline kit SKU DYKS1372C; 4) IV START KIT, Medline kit SKU DYNDV1691B; 5) OUTPATIENT 2 TO 5 YEARS, Medline kit SKU DYNDV2464A.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1056-2026More 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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