3M Recalls Ankle Braces Due to Missing Latex Warning Label
3M is recalling specific ACE and Futuro ankle braces because they contain natural latex rubber but lack the required caution statement.
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 (missing latex warning) on a common allergen, which corresponds to a severity score of 3 (High) per the rubric.
Plain-English summary
3M Company - Health Care Business is recalling the ACE (TM) Brand Deluxe Ankle Brace (Cat. #207736) and the Futuro Quick Strap Ankle Brace (Cat. #47736EN). The recall involves 162,348 units distributed in the US, Australia, Jordan, Republic of Korea, Lebanon, New Zealand, Oman, Qatar, Taiwan, and the United Arab Emirates.
The recall was initiated because the products contain natural latex rubber but do not include the appropriate caution statement on the labeling. This omission creates a risk for individuals with latex allergies who may not be aware of the material's presence.
Consumers who have purchased these specific ankle braces should stop using them and contact 3M for further instructions or a refund. The recall number is Z-0946-2018.
The recalled product
- Product
- ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7
- Manufacturer
- 3M Company - Health Care Business
- Affected units
- 162,348
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 (1)
- All lots
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by 3M Company - Health Care Business under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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