Mueller Hybrid Wraparound Knee Support Recalled for Latex Mislabeling
Mueller Sports Medicine is recalling Hybrid Wraparound Knee Supports because they contain natural rubber despite being labeled as latex-free.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves allergen mislabeling on a common allergen (natural rubber latex), which corresponds to a severity score of 3 (High) per the rubric.
Plain-English summary
Mueller Sports Medicine, Inc. is recalling 135,354 units of the Hybrid Wraparound Knee Support. The product is distributed in boxes containing one unit each. The recall is due to a labeling error where the product is marked as "Not made with Natural Rubber latex" but actually contains natural rubber.
The affected products have the reference number 64217 and UPC number 074676642178. Distribution was limited to the United States, specifically in the states of Arkansas (AR) and Ohio (OH).
Consumers who purchased this product should stop using it. Individuals with a known allergy to natural rubber latex should be particularly cautious, as the presence of the allergen contradicts the product's labeling.
The recalled product
- Product
- Mueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per box
- Manufacturer
- Mueller Sports Medicine, Inc
- Affected units
- 135,354
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)
- Reference number: 64217
- UPC number: 074676642178
Distribution
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