Z-1754-2020Class II

KT RECOVERY+ ICE/HEAT MASSAGE BALL Rolling ball with hot and cold packs that can be interchanged depending on...

Name: Z-1754-2020 KT RECOVERY+ ICE/HEAT MASSAGE BALL Rolling ball with hot and cold packs that can be interchanged depending on...
Creator: KT Health, LLC
Published: 2019-09-16
License: https://open.fda.gov/license/

KT Health, LLC / initiated 2019-09-16 / Terminated

FDA source

KT Health, LLC began a recall of KT RECOVERY+ ICE/HEAT MASSAGE BALL Rolling ball with hot and cold packs that can be interchanged depending on the therapy type desired on 2019-09-16. FDA classified it as Class II and gives the reason as "If over-heated may leak which, if not noticed, may cause hot fluid to come in contact with the user". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1754-2020
Classification: Class II
Status: Terminated
Initiated: 2019-09-16
Posted: 2020-04-21
Terminated: 2021-10-01
Recalling firm: KT Health, LLC
Product: KT RECOVERY+ ICE/HEAT MASSAGE BALL Rolling ball with hot and cold packs that can be interchanged depending on the therapy type desired
Product code: IME Pack, Hot Or Cold, Reusable
Reason for recall: If over-heated may leak which, if not noticed, may cause hot fluid to come in contact with the user.
FDA root cause: Unknown/Undetermined by firm
Action: Recall notifications were sent out on 9/16/2019 by letter to distributors. Firm indicated they used first class mail, email or facsimile. The notice informs users that the Company has received reports of product failures resulting in the release of the hot liquid from the Heat Gel-Core Insert component (orange ball) after being heated in the microwave. These included five reports of skin contact resulting in temporary or medically reversible adverse health consequences (first-degree burns and possibly one second degree burn), one of which required medical treatment. There were also four reports of skin contact with hot liquid that did not result in burns, and several reports of skin contact at room temperature with no adverse consequences The firm is asking Distributors to: 1) Immediately examine your inventory (in all locations), remove from sale/distribution and quarantine product subject to recall. 2) This recall should be carried out to the retailer and consumer level, so to the extent you have further distributed this product, please identify and alert your retailers and notify them at once of this product recall. Your notification to your retailers may be enhanced by including the enclosed sub-recall letter for them. 3) Please return all quarantined/recalled product to our warehouse at the following address for a full refund: KT Health, LLC Attn: Recall Returns 584 East 1100 South, Suite #4 American Fork, UT 84003 4) The firm will cover return shipping costs. If you have other costs kindly call us at: 801- 224-2717 5) Please acknowledge receipt of this recall letter by filling out the attached Return Response form and sending it by any of the following means: a. FAX: 858-947-3832 b. EMAIL: [email protected] c. MAIL: KT Health, LLC Attn: Recall Returns 584 East 1100 South, Suite #4 American Fork, UT 84003 All returns of full products will have the hot gel core insert balls removed and sent for destruction as noted above.
Quantity in commerce: 94,554
Distribution: US Nationwide distribution, no Government Consignees.
Product codes and lots: UPC Codes: 814179022226 814179022561 814179022721

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1754-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1754-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-29	2020-04-21

Product code IME

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)