Philips Recalls eValueMed Infant Heel Warmers and Transport Mattresses
Philips is recalling eValueMed infant heel warmers and transport mattresses because they lack expiration dates and warnings about overheating risks.
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: The recall involves a risk-of-harm product (potential overheating of infant devices) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Philips Electronics North America Corporation is recalling eValueMed Infant Heel Warmers and eValueMed Infant Transport Mattresses. The recall involves 539.156 units that were distributed nationwide to Ohio. These products are disposable heel warmers used to stimulate circulation in infant heels for blood sampling.
The recall was initiated because the products do not bear an expiration date. Additionally, they lack a warning that using the product beyond its expected shelf life may cause it to warm to a temperature above its specification.
Consumers should stop using these products immediately. The source text does not provide specific instructions for disposal or return, nor does it report any illnesses or injuries associated with the use of these devices.
The recalled product
- Product
- eValueMed Infant Transport Mattress 301-1015, Distributed by Tri-anima A disposable heel warmer for use when circulation needs to be stimulated in the infant heel in order for blood sampling to occur
- Manufacturer
- Philips Electronics North America Corporation
- Category
- Medical Device — Infant Care
- Hazard
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 in distribution.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Philips Electronics North America Corporation 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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