Lower riskMedical device recall · FDA · Published November 29, 2021
Philips Medichoice Infant Heel Warmer Recall: FDA Labeling Changes Required
Philips recalls all Medichoice Infant Heel Warmers due to FDA labeling changes needed for 510(k) clearance. Affected units require new regulatory approval before safe use.
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.
Take action
Contact the company
📍Recalling firmPhilips North America Llc222 Jacobs St · Cambridge, MA 02141-2289
“Philips Medichoice Infant Heel Warmer Recall: FDA Labeling Changes Required.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61493-philips-medichoice-infant-heel-warmer-recall-fda-labeling-changes-required. Based on FDA recall #Z-0509-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0509-2022%22&limit=1).
Philips North America Llc recalled the Medichoice Infant Heel Warmer (Reference # 989805643721 1079906) because modified labeling lacks required FDA clearance, according to the FDA. The agency announced the voluntary Class II recall on November 29, 2021.
How to tell if you have it
Brand: Philips
Product: Medichoice Infant Heel Warmer
Reference #: 989805643721 1079906
The hazard
The devices have labeling changes that do not fall within existing FDA clearance, meaning they cannot be distributed or sold without new 510(k) clearance.
Context
GovInfoNow's records show Philips North America Llc has 129 other recalls on record since July 12, 2017. Recent recalls include the Ingenia 1.5T series (August 21, 2026), the Spectral CT 7500 Scanner (August 18, 2026), and the Brilliance CT 64 Medical Scanner (August 7, 2026). Other recent recalls of similar products include Medline Convenience Kits with Unapproved Syringes Recalled: FDA Design Changes (February 27, 2026) and Medline Convenience Kits with Unapproved Syringes Recalled: Design Changes Risk (February 27, 2026).
How to tell if you have this one
All units of the Medichoice Infant Heel Warmer with reference number 989805643721 1079906 are affected. The product was sold by Philips North America.
Brand
Philips
Category
Medical device
FDA recall event · 4 products
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US Nationwide and Canada.
Recall number
Product, codes & lots
Quantity
Z-0506-2022
Infant Heel Warmers w/strap, Reference # 989805603201 1223; All units are impacted
5,164,600 units
Z-0507-2022
Heel Snuggler, Reference # 989805603411 99047; All units are impacted
2,509,100 units (Updated to 2,515,200 as of 2/15/22)
Z-0508-2022
Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T; All units are impacted
4,920,600 units
Z-0509-2022
Medichoice Infant Heel Warmer, Reference # 989805643721 1079906; All units are impacted
2,925,800 units
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the reference number 989805643721 1079906 on the device.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “US Nationwide and Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 58 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0509-2022 (November 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0509-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.