FDA Medical Device Recalls (openFDA)
KT Health, LLC: KT RECOVERY+ ICE/HEAT MASSAGE BALL Rolling ball with hot and cold packs that can be interchanged depending on the therapy type desired
- Recall number
- Z-1754-2020
- 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
- Status
- Terminated
- Initiated
- 2019-09-16
- Posted
- not on file
- Terminated
- 2021-10-01
- Reason
- If over-heated may leak which, if not noticed, may cause hot fluid to come in contact with the user.
- 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: recalls@kttape.com 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
- 94,554
- Distribution
- US Nationwide distribution, no Government Consignees.
- Lot, serial or model codes
- UPC Codes: 814179022226 814179022561 814179022721
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IME
- Firm FEI
- 3007282994
- Firm city
- American Fork
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28