Device recall: Volt Resistance Heated Neck Garment Deep penetrating heat garment and wraps
Class II FDA enforcement event 76787. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
2k Innovations Inc. started this device recall on 15 Apr 2016. The firm address in the FDA record is in Saint Augustine, FL. FDA put the recall in Class II. FDA event 76787 has 12 product records. The first FDA enforcement report date is 19 Apr 2017. The record gives the status Terminated, with the termination date 7 Aug 2019.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide Distribution
Recalling firm
2k Innovations Inc., Saint Augustine, FL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
12 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1802-2017 | Volt Resistance Heated Neck Garment Deep penetrating heat garment and wraps | 22,757 items in total | Class II | Terminated | 19 Apr 2017 |
| Z-1803-2017 | Volt Resistance Heated Lower Back Garment Deep penetrating heat garment and wraps | 22,757 items in total | Class II | Terminated | 19 Apr 2017 |
| Z-1804-2017 | Volt Resistance Heated Therapy Shoulder Wrap Deep penetrating heat garment and wraps | 22,757 items in total | Class II | Terminated | 19 Apr 2017 |
| Z-1805-2017 | Volt Resistance Heated Therapy Foot Wrap Deep penetrating heat garment and wraps | 22,757 items in total | Class II | Terminated | 19 Apr 2017 |
| Z-1806-2017 | Volt Resistance Heated Therapy Knee Wrap Deep penetrating heat garment and wraps | 22,757 items in total | Class II | Terminated | 19 Apr 2017 |
| Z-1807-2017 | Volt Resistance Heated Elbow Garment Deep penetrating heat garment and wraps | 22,757 items in total | Class II | Terminated | 19 Apr 2017 |
| Z-1808-2017 | Volt Resistance Frostie Heated Gloves (All sizes) Deep penetrating heat garment and wraps | 22,757 items in total | Class II | Terminated | 19 Apr 2017 |
| Z-1809-2017 | Volt Resistance Heated Socks (All sizes) Deep penetrating heat garment and wraps | 22,757 items in total | Class II | Terminated | 19 Apr 2017 |
| Z-1810-2017 | Volt Resistance Heated Slipper Black (All sizes) Deep penetrating heat garment and wraps | 22,757 items in total | Class II | Terminated | 19 Apr 2017 |
| Z-1811-2017 | Volt Resistance Heated Slipper Gray (All sizes) Deep penetrating heat garment and wraps | 22,757 items in total | Class II | Terminated | 19 Apr 2017 |
| Z-1812-2017 | Volt Resistance Heated Slipper (All sizes) Deep penetrating heat garment and wraps | 22,757 items in total | Class II | Terminated | 19 Apr 2017 |
| Z-1813-2017 | Volt Resistance Unisex Rechargeable Heated Slipper (All sizes) Deep penetrating heat garment and wraps | 22,757 items in total | Class II | Terminated | 19 Apr 2017 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2016
- 1,232
- Share of these events in Class II
- 91%
- Product records in this event
- 12
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report Z-1802-2017The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 76787. https://recallregister.com/fda/ii/76787/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide Distribution
- What quantity of product is in FDA event 76787?
- The event has 12 product records. The first record gives this quantity:
22,757 items in total
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2016 have the same class?
- 91% of the 1,232 device events that started in 2016 are in Class II.