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.
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 (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
Same manufacturer · United Surgical Associates
See all →- ModerateUnited Surgical Associates Recalls Elastic Ankle Supports for Missing Latex Label
FDA (Devices) · 2015-06-03
- ModerateUnited Surgical Associates Recalls Keo Wrist Braces for Missing Latex Label
FDA (Devices) · 2015-06-03
Same hazard · latex allergy
See all →- ModerateDJO Nylatex Wraps Recalled for Missing Latex Warning Labels
FDA (Devices) · 2020-07-22
- HighCustom Healthcare Systems Recalls Inpatient Dialysis Kits Due to Latex
FDA (Devices) · 2020-02-05
- ModerateMerit Medical Systems Recalls Custom Procedure Kits Due to Latex Labeling Error
FDA (Devices) · 2019-10-09
- HighCardinal Health Recalls ChemoPlus Chemo Spill Kits Due to Latex
FDA (Devices) · 2019-05-15
- HighCardinal Health Recalls ChemoPlus Goggles Due to Latex Mislabeling
FDA (Devices) · 2019-05-15
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