The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0509-2022·Announced 2022-01-26

Medichoice Infant Heel Warmer recalled due to unapproved labeling changes

Philips is recalling 2,925,800 Medichoice Infant Heel Warmer units because labeling was modified beyond the scope of FDA clearance. The devices cannot be sold without new 510(k) approval.

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 an FDA Class II device recall involving non-compliance with the original 510(k) clearance due to unapproved labeling modifications. No illnesses, injuries, or direct safety defects with the device itself have been reported. The issue is regulatory compliance rather than a demonstrated safety hazard.

Plain-English summary

Philips North America LLC is recalling approximately 2,925,800 Medichoice Infant Heel Warmer units (Reference # 989805643721 1079906). All units with the modified labeling are included in this recall.

After the device received FDA clearance, Philips made changes to the product labeling that extend beyond the scope of the original 510(k) clearance. These labeling modifications were not reviewed or approved by the FDA, making distribution or sale of the affected devices non-compliant with federal regulations.

The recalled devices were distributed nationwide in the United States and Canada. All users should discontinue use of affected units and contact Philips North America LLC for instructions regarding return or replacement of devices with compliant labeling.

The recalled product

Product
Medichoice Infant Heel Warmer, Reference # 989805643721 1079906
Manufacturer
Philips North America Llc
Category
Medical Device — Neonatal/Infant Equipment
Hazard
Affected units
2,925,800

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.

See all 4 products in this recall →

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