← FDA ENFORCEMENT
Z-0189-2027Class 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
2026-10-21
Distribution
US Nationwide distribution in the state of NY.
Firm state
IL
Product quantity
30 kits
Initiated by
Voluntary: Firm initiated
Reason for recall
Discrepancy in the shelf-life of a component
Product description
Medline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395A
Code / lot info
UDI/DI 10195327174156 (each) 40195327174157 (case), Lot Number 22GBW912
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 →