Data Foundry

Medical device recalls 2015

Elastic Ankle Support — Class II medical device recall Z-1664-2015

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 numberZ-1664-2015
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmUnited Surgical Associates, Fort Wayne, IN, United States
Recall initiated2015-04-13
Classified2015-05-23
Reported by FDA2015-06-03
Terminated2015-07-14
Quantity1,278
Reason classeslabeling
Lot numbersAP20140815001

Product

Elastic Ankle Support. 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-1664-2015. 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.