FDA Device recall Z-1666-2015
Keo Brace, elastic wrist brace for carpal tunnel
- FDA Device
- Class II
- terminated
- Published 2015-06-03
On 2015-06-03 the FDA classified a Class II recall of Keo Brace, elastic wrist brace for carpal tunnel by United Surgical Associates, citing the product does not bear the caution label regarding latex content. Potential for Allergic skin reaction.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1666-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-13 |
| Published | 2015-06-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | United Surgical Associates |
| Distribution | HI |
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
The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction
Identifiers
| code_info | Product # i-75100 Lot# AK20140801002 |
|---|
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-1666-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.