Breg Recalls Sterile Polar Pads Due to Packaging Damage
Breg Inc is recalling 44,883 units of Sterile Polar Pads manufactured between January 2010 and October 2012 because packaging damage may compromise sterility.
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 a medical device where packaging damage may compromise sterility assurance, creating a risk of harm (infection) without reported injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Breg Inc is recalling 44,883 units of BREG Sterile Polar Pads. The affected products include models 02510, 09901, 02330, 02350, 02490, 02356, 02496, 02410, and 02430, with a specific reference to 02356 Rev M. The recall covers products manufactured from January 2010 through October 2012.
The recall was initiated because Breg determined that some of these products may have sustained damage to the packaging. This damage may compromise the product's sterility assurance. The affected products were distributed nationwide in the United States and in Australia, Singapore, Chile, and Latvia.
Consumers and healthcare facilities should stop using the affected Sterile Polar Pads and contact Breg Inc for instructions on how to return or dispose of the products.
The recalled product
- Product
- BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 02510, 09901, 02330, 02350, 02490, 02356, 02496, 02410, 02430. Local anesthetic effect.
- Manufacturer
- Breg Inc
- Affected units
- 44,883
Distribution
Distributed nationwide across the United States.
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.
See all 2 products in this recall →Related recalls
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