Medline Foot Ankle Convenience Kit Recalled for Shelf-Life Discrepancy
Medline is recalling 30 Foot Ankle convenience kits due to a discrepancy in the shelf-life of a component.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as Class II due to a shelf-life discrepancy in a component. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Medline Industries, LP is recalling 30 Medline convenience kits labeled as FOOT ANKLE (SKU DYNJ65395A) due to a discrepancy in the shelf-life of a component. The affected products are identified by UDI/DI 10195327174156 (each) and 40195327174157 (case), with Lot Number 22GBW912.
The recall covers products distributed nationwide in the state of New York. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Consumers should check their inventory for the specific lot number and contact Medline Industries, LP for further instructions or a refund.
The recalled product
- Product
- Medline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395A
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Convenience Kit
- Hazard
- Affected units
- 30
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 10195327174156 (each) 40195327174157 (case)
- Lot Number 22GBW912
Distribution
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