Agency classClass IIOur severity:High FDA (Devices)·Z-1316-2016·Announced 2016-04-13

Recall of 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 after shelf life.

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 is classified as FDA Class II. The hazard involves a risk of overheating (burn injury) for infants, which is a risk-of-harm product 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 (model 301-1223) and eValueMed Infant Transport Mattresses. The recall involves 539.156 units distributed nationwide to Ohio. The products are distributed by Tri-anim.

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. This poses a risk of overheating for infants using the devices.

Consumers should stop using the affected products immediately. The recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: evaluemed Infant Heel Warmer 301-1223; Distributed by Tri-anim 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: burn-injury
overheating

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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 2 products in this recall →

Same manufacturer · Philips Electronics North America Corporation

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Same hazard · burn injury