Volt Resistance Heated Therapy Shoulder Wrap Deep penetrating heat… — Class II medical device recall Z-1804-2017
Terminated recall by 2k Innovations Inc., reported 2017-04-19, distributed nationwide. During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product in
| Recall number | Z-1804-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | 2k Innovations Inc., Saint Augustine, FL, United States |
| Recall initiated | 2016-04-15 |
| Classified | 2017-04-12 |
| Reported by FDA | 2017-04-19 |
| Terminated | 2019-08-07 |
| Distributed | Nationwide (US) |
| Quantity | 22,757 items |
| Reason classes | unapproved product |
Product
Volt Resistance Heated Therapy Shoulder Wrap Deep penetrating heat garment and wraps
Reason for recall
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
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-1804-2017. 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.