The Recall Desk
ModerateFDA (Devices)·Z-0506-2022·Announced 2022-01-26

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.

What this means for you

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
Category
Medical Device — Infant Care Equipment
Hazard
  • labeling-error

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.

Related recalls

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