Infant Heel Warmers Recalled for Unauthorized Labeling Changes
Philips North America is recalling 5,164,600 units of Infant Heel Warmers due to labeling changes made after FDA clearance without new approval. The devices cannot be distributed or sold without new FDA 510(k) clearance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a regulatory labeling compliance issue with no reported illnesses, injuries, or described hazards in the source. The FDA Class II designation and prohibition on distribution warrant 'Moderate' rather than 'Low,' but the absence of any actual harm or specific risk prevents a higher score.
Plain-English summary
Philips North America LLC is recalling all 5,164,600 units of Infant Heel Warmers with strap (Reference # 989805603201 1223) distributed in the US and Canada.
After the device received FDA clearance, Philips made changes to the product labeling that fall outside the scope of the original FDA clearance. These labeling changes mean the devices cannot be legally distributed or sold without obtaining new FDA 510(k) clearance.
The recalled product
- Product
- Infant Heel Warmers w/strap, Reference # 989805603201 1223
- Manufacturer
- Philips North America Llc
- Hazard
- Affected units
- 5,164,600
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All units are impacted
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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