The Recall Desk
HighFDA (Devices)·Z-0508-2022·Announced 2022-01-26

Cardinal Infant Heel Warmer recalled due to unapproved labeling changes

Philips North America recalls Cardinal Infant Heel Warmers because labeling was changed without FDA approval. The devices cannot be sold or distributed without new FDA clearance.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA classified this as Class II, indicating potential health risk. However, no illnesses or injuries have been reported. The hazard is regulatory—unapproved labeling changes—rather than a demonstrated safety failure.

Plain-English summary

Philips North America LLC is recalling the Cardinal Infant Heel Warmer because of unauthorized labeling changes. The FDA had approved the device with specific labeling, but Philips later made changes to that labeling without FDA authorization. The current labeling does not match what was approved.

These devices were distributed to healthcare facilities and consumers across the United States and Canada. Approximately 4.9 million units are affected.

Healthcare providers and consumers should discontinue use of the device. Contact Philips North America LLC for instructions on next steps. The company must obtain new FDA approval before these devices can be sold or used again.

The recalled product

Product
Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T
Manufacturer
Philips North America Llc
Category
Medical Device — Neonatal Warming Device
Hazard
  • mis-labeling

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

Same category