FDA-Device2026-01-21Class IIPROCESSING DEFECT
Medline cardiac surgery kits recalled for stuck IV check valves
What this means
Medline has recalled eight models of cardiac surgery kits that contain B. Braun IV administration sets. The check valve components in these sets may become stuck in either the open or closed position, which could affect fluid delivery during surgery. No injuries have been reported.
- Check if you have one of the recalled kits by matching your SKU and lot number to the FDA notice
- Stop using any affected kits immediately
- Contact Medline or the FDA with questions about your specific units
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
633 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) 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1050-2026More 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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