FDA Device recall Z-1802-2017
Volt Resistance Heated Neck Garment Deep penetrating heat garment and wraps
- FDA Device
- Class II
- terminated
- Published 2017-04-19
On 2017-04-19 the FDA classified a Class II recall of Volt Resistance Heated Neck Garment Deep penetrating heat garment and wraps by 2k Innovations, citing during an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1802-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-15 |
| Published | 2017-04-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | 2k Innovations |
| Distribution | US |
Product
Volt Resistance Heated Neck Garment Deep penetrating heat garment and wraps
Reason
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
Identifiers
| code_info | Item #VH-NECK |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1802-2017%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.