CLASS II Device recall · Reported 13 Apr 2016 · FDA Enforcement Report

evaluemed Infant Heel Warmer recalled by Philips Electronics North

Philips Electronics North America is recalling evaluemed Infant Heel Warmer 301-1223, distributed nationwide in the US. The recall was initiated on 10 Feb 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll in distribution.

Quantity recalled539.156

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1316-2016
FDA event ID: 73281
Recalling firm: Philips Electronics North America, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 10 Feb 2016
FDA classified: 4 Apr 2016
Reported: 13 Apr 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Temperature Abuse
Device type: Other Medical Devices

Timeline

10 Feb 2016	Recall initiated by company
4 Apr 2016	Classified by FDA	+54 days
13 Apr 2016	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

eValueMed Infant Heel Warmers and eValueMed Infant Transport Mattresses bear no expiration date, nor any warning that product used beyond its expected shelf life may warm to temperature above its specification.

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

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

Where it was distributed

Nationwide distribution to Ohio only.

Nationwide Ohio

Questions about this recall

Is evaluemed Infant Heel Warmer 301-1223 recalled?

Yes. Philips Electronics North America recalled evaluemed Infant Heel Warmer 301-1223 on 10 Feb 2016. The recall is Class II and its status is Terminated. Recall number Z-1316-2016.

Why was it recalled?

Which lots are affected?

All in distribution.

Where was it sold?

Nationwide distribution to Ohio only.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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