United Surgical Associates Recalls Elastic Ankle Supports for Missing Latex Label
United Surgical Associates is recalling 1,278 Elastic Ankle Supports because they lack a caution label regarding latex content, posing a risk of allergic skin reactions.
What this means for you
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 FDA Class II, but the hazard is a labeling error (missing latex warning) rather than a structural defect or contamination, and no illnesses or injuries are reported in the source text.
Plain-English summary
United Surgical Associates is recalling 1,278 units of Elastic Ankle Supports in Small, Medium, and Large sizes. The specific products affected are identified by Product Numbers i-94103, i-94105, and i-94107, all associated with Lot Number AP20140815001. The recall is limited to domestic distribution in Hawaii and international markets.
The recall was initiated because the products do not bear the required caution label regarding their latex content. This labeling omission creates a potential for allergic skin reactions in individuals sensitive to latex.
Consumers who have purchased these specific Elastic Ankle Supports should stop using them and contact United Surgical Associates for further instructions or a refund. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Elastic Ankle Support. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.
- Manufacturer
- United Surgical Associates
- Affected units
- 1,278
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 recalled by United Surgical Associates 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.
See all 3 products in this recall →Related recalls
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