Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Infant Heel Warmers w/strap Recalled by Philips North America Llc Due to After the device was cleared by the FDA,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Philips North America Llc directly.
Affected Products
Infant Heel Warmers w/strap, Reference # 989805603201 1223
Quantity: 5,164,600 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Philips North America Llc
Philips North America Llc has 301 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report