CLASS II Device recall · Reported 20 Feb 2013 · FDA Enforcement Report
Sterile Polar Pads recalled by Breg
Breg is recalling BREG Sterile Polar Pads, distributed nationwide in the US. The recall was initiated on 14 Jan 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0804-2013
- FDA event ID
- 64177
- Recalling firm
- Breg, Carlsbad, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Jan 2013
- FDA classified
- 12 Feb 2013
- Reported
- 20 Feb 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 14 Jan 2013 | Recall initiated by company | |
| 12 Feb 2013 | Classified by FDA | +29 days |
| 20 Feb 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution-USA (nationwide) and the countries of Australia, Singapore, Chile, Latvia.
Questions about this recall
Is Sterile Polar Pads recalled?
Yes. Breg recalled Sterile Polar Pads on 14 Jan 2013. The recall is Class II and its status is Terminated. Recall number Z-0804-2013.
Why was it recalled?
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.
Which lots are affected?
Affected product will be identified by date of manufacture from January 2010 through October 2012
Where was it sold?
Worldwide Distribution-USA (nationwide) and the countries of Australia, Singapore, Chile, Latvia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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