United Surgical Associates Recalls Elastic Knee Supports for Missing Latex Label
United Surgical Associates is recalling 1,260 Elastic Knee Supports because they lack a caution label regarding latex content, posing a risk of allergic skin reactions.
What this means for you
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 (latex) on a medical device, which fits the 'High' severity criterion for allergen mislabeling on common allergens, even though no illnesses are reported.
Plain-English summary
United Surgical Associates is recalling 1,260 units of Elastic Knee Supports (Product # i-95103, i-95105, and i-95107; Lot # AP20140815001). The recall was initiated because the products do not bear the required caution label regarding their latex content.
The missing label creates a potential for allergic skin reactions in individuals sensitive to latex. The recalled products were distributed domestically in Hawaii and internationally.
Consumers with these products should stop using them and contact United Surgical Associates for further instructions.
The recalled product
- Product
- Elastic Knee 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
- 1,260
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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