Breg Recalls Knee Sleeves for Missing Latex Warning Labels
Breg Inc is recalling specific knee sleeves because they contain latex but lack the required caution labels.
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 criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Breg Inc is recalling the Economy Elastic Knee Sleeve Open (Model No. 121414 and 121415) and K-Lite Knee 2 Stays with Visco. The recall involves 20 units from Lot No. 705764.
The products are being recalled because they contain latex but were not labeled with the required caution label. This labeling error poses a risk to individuals with latex allergies.
The affected products were distributed nationwide in the United States and worldwide, specifically in the states of Texas, Kentucky, Indiana, and Florida. Consumers should stop using these products if they have a latex allergy and contact the manufacturer for instructions.
The recalled product
- Product
- Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usage: The product is intended to provide flexible knee support.
- Manufacturer
- Breg Inc
- Affected units
- 20
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)
- Lot No. 705764
Distribution
Part of a larger recall action
This product is one of 2 recalled by Breg Inc 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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