Keo Brace — Class II medical device recall Z-1666-2015
Terminated recall by United Surgical Associates, reported 2015-06-03. The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction
| Recall number | Z-1666-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | United Surgical Associates, Fort Wayne, IN, United States |
| Recall initiated | 2015-04-13 |
| Classified | 2015-05-23 |
| Reported by FDA | 2015-06-03 |
| Terminated | 2015-07-14 |
| Quantity | 756 |
| Reason classes | labeling |
| Lot numbers | AK20140801002 |
Product
Keo Brace, elastic wrist brace for carpal tunnel. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.
Reason for recall
The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction
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-1666-2015. 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.