Breg Polar Dressing Recalled for Thickness and Durability Defects
Breg Inc. is recalling Polar Dressing units that are thinner than specified, making them less durable and prone to tearing.
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 2/5 (Moderate).
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. The hazard involves a product defect (thickness/durability) and mislabeling without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Breg Inc., an Orthofix Company, is recalling 502 units of the Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg (PN 10630). The product is used with cold therapy pads to provide an insulation barrier between the pad and the patient's skin.
The recall was initiated because the Polar Dressing does not meet the required thickness specifications. The dressing in the sterile pouch measures 0.010 inches instead of the specified 0.020 inches. This reduction in thickness makes the dressing less durable and subject to tearing. The product is also mislabeled.
The affected units are identified by Lot # D101564. The products were distributed nationwide in the USA and in Nova Scotia. Consumers should stop using the affected dressings and contact the manufacturer for further instructions.
The recalled product
- Product
- Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 Used with cold therapy pads to provide insulation barrier between the pad and patient's skin.
- Manufacturer
- Breg Inc, An Orthofix Company
- Affected units
- 502
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 # D101564
Distribution
Distributed nationwide across the United States.
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