FDA Device recall Z-0804-2013
BREG Sterile Polar Pads
- FDA Device
- Class II
- terminated
- Published 2013-02-20
On 2013-02-20 the FDA classified a Class II recall of BREG Sterile Polar Pads by Breg, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0804-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-01-14 |
| Published | 2013-02-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Breg |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | Affected product will be identified by date of manufacture from January 2010 through October 2012 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0804-2013%22
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