Recall
FDAHealthNovember 26, 2025

Medline Industries, LP — 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 PER

⚠️ 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.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
November 26, 2025

US Nationwide distribution.

What's affected?

Product
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.
Lot code
25HMC337

Additional details

Medline kit SKU DYNJ0395085V,UDI/DI 10198459313745 (EA) 40198459313746 (CS), Lot Number 25HMC337; Medline kit SKU DYNJ66311C,UDI/DI 10198459364556 (EA) 40198459364557 (CS), Lot Number 25KBG419; Medline kit SKU DYNJ86770,UDI/DI 10195327674229 (EA) 40195327674220 (CS), Lot Number 25IBU284; Medline kit SKU DYNJ86770,UDI/DI 10195327674229 (EA) 40195327674220 (CS), Lot Number 25KBJ623; Medline kit SKU DYNJ909643F,UDI/DI 10198459392603 (EA) 40198459392604 (CS), Lot Number 25HBU964; Medline kit SKU DYNJ909643F,UDI/DI 10198459392603 (EA) 40198459392604 (CS), Lot Number 25IBV819; Medline kit SKU DYNJ909643F,UDI/DI 10198459392603 (EA) 40198459392604 (CS), Lot Number 25KBF028.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 338 units.

View original FDA notice →

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