Polar Dressing — Class II medical device recall Z-2326-2012
Terminated recall by Breg Inc, An Orthofix Company, reported 2012-09-12, distributed nationwide. This recall has been initiated due to confirmation that the Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg doe
| Recall number | Z-2326-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Breg Inc, An Orthofix Company, Carlsbad, CA, United States |
| Recall initiated | 2010-08-11 |
| Classified | 2012-09-06 |
| Reported by FDA | 2012-09-12 |
| Terminated | 2012-09-06 |
| Distributed | Nationwide (US) |
| Quantity | 502 units |
| Reason classes | labeling, sterility |
| Lot numbers | D101564 |
Product
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.
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.
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-2326-2012. 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.