Z-0803-2013Class II

BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U XL STER, Mfg.Date...

Name: Z-0803-2013 BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U XL STER, Mfg.Date...
Creator: Breg Inc
Published: 2013-01-14
License: https://open.fda.gov/license/

Breg Inc / initiated 2013-01-14 / Terminated / root cause: packaging

FDA source

Breg Inc began a recall of 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... on 2013-01-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0803-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-14
Posted: 2013-02-12
Terminated: 2013-07-01
Recalling firm: Breg Inc
Product: 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 code: ILO Pack, Hot Or Cold, Water Circulating
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.
Root cause tag: packaging
FDA root cause: Packaging
Action: The firm, BREG, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 14, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine your inventory and quarantine the product; complete the Return Response Form by email, Fax or mail; and contact Breg for a Return Authorization for the affected product and request replacement by contacting Breg Customer Care at 800-321-0607. Note: response is required even if you have no affected inventory. Should you have any questions regarding this communication or need to report an adverse event, please contact Breg Customer Care at 800-321-0607.
Quantity in commerce: 44,883 units
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Australia, Singapore, Chile, Latvia.
Product codes and lots: Affected product will be identified by date of manufacture from January 2010 through October 2012.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0803-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0803-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-20	2013-02-12
Z-0804-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-20	2013-02-12

Product code ILO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)