Recall events
/
Event 76787
Event summary
Timeline bucket April 15, 2016
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording 2k Innovations Inc.
Dossier provenance
Source snapshots represented here
openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Complete imported group
Every recalled product in this event
12 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 12
Volt Resistance Heated Neck Garment Deep penetrating heat garment and wraps
Z-1802-2017
Recall number Z-1802-2017
Initiated April 15, 2016
Classification Class II
Status Terminated
Quantity 22,757 items in total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling False and Misleading
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1802-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[10364]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
Code information Item #VH-NECK
Distribution pattern Nationwide Distribution
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[26116]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 12
Volt Resistance Heated Lower Back Garment Deep penetrating heat garment and wraps
Z-1803-2017
Recall number Z-1803-2017
Initiated April 15, 2016
Classification Class II
Status Terminated
Quantity 22,757 items in total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling False and Misleading
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1803-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[34237]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
Code information Item #VH-BACK
Distribution pattern Nationwide Distribution
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[26131]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 12
Volt Resistance Heated Therapy Shoulder Wrap Deep penetrating heat garment and wraps
Z-1804-2017
Recall number Z-1804-2017
Initiated April 15, 2016
Classification Class II
Status Terminated
Quantity 22,757 items in total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling False and Misleading
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1804-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[15961]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
Code information Item #VH-SHOULDER
Distribution pattern Nationwide Distribution
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19972]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 12
Volt Resistance Heated Therapy Foot Wrap Deep penetrating heat garment and wraps
Z-1805-2017
Recall number Z-1805-2017
Initiated April 15, 2016
Classification Class II
Status Terminated
Quantity 22,757 items in total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling False and Misleading
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1805-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[10371]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
Code information Item #VH-FOOT
Distribution pattern Nationwide Distribution
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[20001]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 12
Volt Resistance Heated Therapy Knee Wrap Deep penetrating heat garment and wraps
Z-1806-2017
Recall number Z-1806-2017
Initiated April 15, 2016
Classification Class II
Status Terminated
Quantity 22,757 items in total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling False and Misleading
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1806-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[10367]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
Code information Item #VH-KNEE
Distribution pattern Nationwide Distribution
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19936]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 12
Volt Resistance Heated Elbow Garment Deep penetrating heat garment and wraps
Z-1807-2017
Recall number Z-1807-2017
Initiated April 15, 2016
Classification Class II
Status Terminated
Quantity 22,757 items in total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling False and Misleading
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1807-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[27532]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
Code information Item #VH-ELBOW
Distribution pattern Nationwide Distribution
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[24055]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 12
Volt Resistance Frostie Heated Gloves (All sizes) Deep penetrating heat garment and wraps
Z-1808-2017
Recall number Z-1808-2017
Initiated April 15, 2016
Classification Class II
Status Terminated
Quantity 22,757 items in total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling False and Misleading
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1808-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45575]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
Code information Item #GL-7V-FR
Distribution pattern Nationwide Distribution
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19507]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 12
Volt Resistance Heated Socks (All sizes) Deep penetrating heat garment and wraps
Z-1809-2017
Recall number Z-1809-2017
Initiated April 15, 2016
Classification Class II
Status Terminated
Quantity 22,757 items in total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling False and Misleading
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1809-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[20672]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
Code information Item #3V-SK
Distribution pattern Nationwide Distribution
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19968]
FDA event record
· Exact recall-number query on openFDA
device · product 9 of 12
Volt Resistance Heated Slipper Black (All sizes) Deep penetrating heat garment and wraps
Z-1810-2017
Recall number Z-1810-2017
Initiated April 15, 2016
Classification Class II
Status Terminated
Quantity 22,757 items in total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling False and Misleading
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1810-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45570]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
Code information Item #VS-BK
Distribution pattern Nationwide Distribution
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19946]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1811-2017
Initiated April 15, 2016
Classification Class II
Status Terminated
Quantity 22,757 items in total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling False and Misleading
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1811-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[56283]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
Code information Item #VS-GR
Distribution pattern Nationwide Distribution
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19511]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1812-2017
Initiated April 15, 2016
Classification Class II
Status Terminated
Quantity 22,757 items in total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling False and Misleading
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1812-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45576]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
Code information Item #VS-FB
Distribution pattern Nationwide Distribution
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[26053]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1813-2017
Initiated April 15, 2016
Classification Class II
Status Terminated
Quantity 22,757 items in total
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling False and Misleading
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1813-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[20673]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
Code information Item #VS-PU
Distribution pattern Nationwide Distribution
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[26095]
FDA event record
· Exact recall-number query on openFDA
