Dressing — Class II medical device recall Z-1904-2017
Terminated recall by Breg Inc, reported 2017-05-10, distributed nationwide. They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
| Recall number | Z-1904-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Breg Inc, Carlsbad, CA, United States |
| Recall initiated | 2017-03-30 |
| Classified | 2017-05-01 |
| Reported by FDA | 2017-05-10 |
| Terminated | 2017-06-23 |
| Distributed | Nationwide (US) |
| Quantity | 2,609 units |
| Reason classes | sterility |
Product
Dressing, Knee L/XL, P/N 04708 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.
Reason for recall
They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
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-1904-2017. 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.