Breg Inc: Medical Device Recall in 2013 - (Recall #: Z-0803-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 10903, 10703, 09101, 09111, 09131, 09731, 09611, 09621, and 09631. Local anesthetic effect.

Product Classification:

Class II

Date Initiated: January 14, 2013

Date Posted: February 20, 2013

Recall Number: Z-0803-2013

Event ID: 64177

Reason for Recall:

The recall was initiated because Breg has determined that some Sterile Polar Pads products manufactured from January 2010 to October 2012 may have sustained damage to the product packaging which may compromise product sterility assurance.

Status: Terminated

Product Quantity: 44,883 units

Code Information:

Affected product will be identified by date of manufacture from January 2010 through October 2012.

Distribution Pattern:

Worldwide Distribution-USA (nationwide) and the countries of Australia, Singapore, Chile, Latvia.

Voluntary or Mandated:

Voluntary: Firm initiated