BREG Sterile Polar Pads — Class II medical device recall Z-0804-2013
Terminated recall by Breg Inc, reported 2013-02-20, distributed nationwide. The recall was initiated because Breg has determined that some Sterile Polar Pads products manufactured from J
| Recall number | Z-0804-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Breg Inc, Carlsbad, CA, United States |
| Recall initiated | 2013-01-14 |
| Classified | 2013-02-12 |
| Reported by FDA | 2013-02-20 |
| Terminated | 2013-07-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CL, LV, SG |
| Quantity | 44,883 units |
| Reason classes | sterility |
| Model numbers | 02330, 02350, 02356, 02410, 02430, 02490, 02496, 02510, 09901 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0804-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.