← FDA ENFORCEMENT
Z-2433-2026Class 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
2026-06-24
Distribution
US Nationwide distribution. OUS distribution pending.
Firm state
IL
Product quantity
49,654 kits total
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason for recall
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Product description
Medline convenience kits: WT LAVH PACK DYNJ46609F
Code / lot info
DYNJ46609F UDI-DI 10198459403989 lot 25JBS436
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 →