United Surgical Associates Recalls Keo Wrist Braces for Missing Latex Label
United Surgical Associates is recalling 756 Keo elastic wrist braces 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) with no reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
United Surgical Associates is recalling 756 units of the Keo elastic wrist brace, a limb orthosis intended for carpal tunnel support. The recall is due to a labeling defect: the product does not bear the required caution label regarding its latex content.
The missing label creates a potential for allergic skin reactions in individuals sensitive to latex. The affected units are identified by Product # i-75100 and Lot# AK20140801002. The distribution pattern is listed as Domestic: HI and International: None.
Consumers who have purchased this specific lot of Keo wrist braces should stop using the product if they are sensitive to latex. They should contact United Surgical Associates for further instructions or a refund.
The recalled product
- Product
- Keo Brace, elastic wrist brace for carpal tunnel. 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
- 756
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)
- Product # i-75100 Lot# AK20140801002
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
Same manufacturer · United Surgical Associates
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FDA (Devices) · 2015-06-03
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