FDA-Device2026-01-21Class IIPROCESSING DEFECT
Medline surgical kits with B. Braun IV sets recalled for stuck check valve
What this means
Medline surgical kits containing B. Braun IV Administration Sets have been recalled because the check valve components may become stuck in the open or closed position. This could affect fluid flow during medical procedures. The recall affects four specific surgical kit types distributed nationwide.
- Check if you have one of the affected kits: RR-PLASTIC CRANIOFACIAL PK-LF (SKU DYNJ0395085V), NH PERI DISC PACK (SKU DYNJ66311C), DISCECTOMY PACK (SKU DYNJ86770), or TOTAL KNEE (SKU DYNJ909643F)
- Do not use affected kits if you have them in stock
- Contact your Medline representative or the FDA for return or replacement instructions
- Report any issues or injuries to the FDA MedWatch program
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
338 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) RR-PLASTIC CRANIOFACIAL PK-LF, Medline kit SKU DYNJ0395085V; 2) NH PERI DISC PACK, Medline kit SKU DYNJ66311C; 3) DISCECTOMY PACK, Medline kit SKU DYNJ86770; 4) TOTAL KNEE, Medline kit SKU DYNJ909643F.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1060-2026More 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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