Breg Inc, An Orthofix Company: Medical Device Recall in 2012 - (Recall #: Z-2326-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: August 11, 2010

Date Posted: September 12, 2012

Recall Number: Z-2326-2012

Event ID: 58247

Reason for Recall:

This recall has been initiated due to confirmation that the Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg does not meet the required thickness as specified. The dressing in the sterile pouch measures a thickness of 0.010" instead of 0.020". This change in thickness makes the dressing thinner, less durable and subject to tearing. The product is mislabeled.

Status: Terminated

Product Quantity: 502 units

Code Information:

Lot # D101564

Distribution Pattern:

Worldwide distribution: USA (nationwide) and country of: Nova Scotia.

Voluntary or Mandated:

Voluntary: Firm initiated