TENNIS ELBOW SUPPORT — Class II medical device recall Z-0712-2017
Terminated recall by DeRoyal Industries Inc, reported 2016-12-14, distributed nationwide. DeRoyal received complaints of mold on Tennis Elbow Straps.
| Recall number | Z-0712-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, Powell, TN, United States |
| Recall initiated | 2016-11-07 |
| Classified | 2016-12-06 |
| Reported by FDA | 2016-12-14 |
| Terminated | 2022-01-13 |
| Distributed | Nationwide (US) |
| Quantity | 56 units |
| Reason classes | microbial contamination |
| Pathogens | mold |
| Lot numbers | 42249787, 42490802, 42737908, 42944296, 43000801, 43031421, 43036118, 43068890, 43134851, 43454441, 4363109 |
| Model numbers | 200A10 |
Product
TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis
Reason for recall
DeRoyal received complaints of mold on Tennis Elbow Straps.
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-0712-2017. 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.