Breg Recalls Knee Supports for Missing Latex Warning Labels
Breg Inc is recalling two knee support models because they contain latex but lack the required caution label.
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 common allergen, which corresponds to a High severity score per the rubric, as no illnesses or injuries are reported in the source text.
Plain-English summary
Breg Inc is recalling the Economy Elastic Knee Sleeve Open and the K-Lite Knee 2 Stays with Visco (Model No. 122015). The recall involves 2 units of the K-Lite model, specifically Lot No. 705593. The products are intended to provide flexible knee support.
The recall was initiated because the products contain latex but were not labeled with the required caution label. This labeling omission poses a risk to individuals with latex allergies.
The products were distributed nationwide in the United States and worldwide, with specific distribution noted in Texas, Kentucky, Indiana, and Florida. Consumers should stop using the affected products and contact Breg Inc for further instructions.
The recalled product
- Product
- K-Lite Knee 2 Stays with Visco, Model No. 122015. Product Usage: The product is intended to provide flexible knee support.
- Manufacturer
- Breg Inc
- Affected units
- 2
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. 705593
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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