← FDA ENFORCEMENT
Z-1056-2026Class II

Medline Industries, LP

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Medline Industries, LP
Product type
Device
Status
Ongoing
Report date
2026-01-21
Distribution
US Nationwide distribution.
Firm state
IL
Product quantity
5314 units
Initiated by
Voluntary: Firm initiated
Reason for recall

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.

Product description

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.

Code / lot info

Medline kit SKU DYKM1980C, UDI/DI 10195327608309 (EA) 40195327608300 (CS), Lot Number 25JBB147; Medline kit SKU DYKM1980C, UDI/DI 10195327608309 (EA) 40195327608300 (CS), Lot Number 25KBL305; Medline kit SKU DYKM2137B, UDI/DI 10198459285615 (EA) 40198459285616 (CS), Lot Number 25HBT834; Medline kit SKU DYKM2137B, UDI/DI 10198459285615 (EA) 40198459285616 (CS), Lot Number 25IBJ757; Medline kit SKU DYKM2137B, UDI/DI 10198459285615 (EA) 40198459285616 (CS), Lot Number 25JBJ557; Medline kit SKU DYKS1372C, UDI/DI 10195327373504 (EA) 40195327373505 (CS), Lot Number 25JLA480; Medline kit SKU DYNDV1691B, UDI/DI 10195327658472 (EA) 40195327658473 (CS), Lot Number 25HBI335; Medline kit SKU DYNDV1691B, UDI/DI 10195327658472 (EA) 40195327658473 (CS), Lot Number 25IBE523; Medline kit SKU DYNDV1691B, UDI/DI 10195327658472 (EA) 40195327658473 (CS), Lot Number 25JBM702; Medline kit SKU DYNDV2464A, UDI/DI 10195327065911 (EA) 40195327065912 (CS), Lot Number 25IBV942.

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →