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.
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 3/5 (High).
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
- Hazard
- Affected units
- 4,920,600
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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