Z-0509-2022Class II

Medichoice Infant Heel Warmer, Reference # 989805643721 1079906

Name: Z-0509-2022 Medichoice Infant Heel Warmer, Reference # 989805643721 1079906
Creator: Philips North America Llc
Published: 2021-11-29
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2021-11-29 / Open, Classified / root cause: labeling and UDI

FDA source

Philips North America Llc began a recall of Medichoice Infant Heel Warmer, Reference # 989805643721 1079906 on 2021-11-29. FDA classified it as Class II and gives the reason as "After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k)...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0509-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-11-29
Posted: 2022-01-19
Recalling firm: Philips North America LLC
Product: Medichoice Infant Heel Warmer, Reference # 989805643721 1079906
Product code: IMD Pack, Hot Or Cold, Disposable
Reason for recall: After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.
Root cause tag: labeling and UDI
FDA root cause: No Marketing Application
Action: URGENT Medical Device Recall notification letters dated November 2021 were sent to customers. The actions that should be taken by the customer / user to prevent risks to patients or users 1. Identify all Infant Heel Warmers and Heel Snugglers in your possession. 2. Destroy all Infant Heel Warmers and Heel Snugglers, regardless if they are expired or not. 3. Please complete the Urgent Medical Device Recall Response Form online by using the URL provided on the form. 4. Identify and source an alternative device to meet your needs. Philips will no longer offer the Infant Heel Warmers and Heel Snugglers. 5. Share this communication with your staff and other impacted departments and organizations. If you need any further information concerning this issue, please email [email protected] (preferred communication path} or contact+ 1-629-215-7280 Monday through Friday, 8AM - 3PM Central Standard Time. If you email [email protected], you will receive an email response with the link to submit your Recall Acknowledgement form online, as well as a response to your inquiry.
Quantity in commerce: 2,925,800 units
Distribution: US Nationwide and Canada.
Product codes and lots: All units are impacted

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0509-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0506-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-01-26	2022-01-19
Z-0507-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-01-26	2022-01-19
Z-0508-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-01-26	2022-01-19
Z-0509-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-01-26	2022-01-19

Product code IMD

K936084Class IOmni Warm Gel PacksOmni Therm, Inc. / cleared 1994-03-31

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)