← FDA ENFORCEMENT
Z-0137-2026Class 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
2025-10-22
Distribution
US Nationwide distribution in the states of MO.
Firm state
IL
Product quantity
950 units
Initiated by
Voluntary: Firm initiated
Reason for recall
Specific items and lots of Medline Kits may contain Clearlink IV Sets which Baxter recalled due to customer reports of leaking.
Product description
Medline Adult Anesthesia Set, REF DYNJ39985G
Code / lot info
UDI/DI 10198459062353 (EA) 40198459062354 (Case), Lot Numbers: 25GMB464
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 →