Agency classClass IIOur severity:High FDA (Devices)·Z-2095-2021·Announced 2021-07-28

Infant Heel Warmer Recalled Due to Risk of Rupture and Contents Splashing

Cardinal Health is recalling 2.9 million infant heel warmers that may rupture or leak during activation, potentially splashing heated contents onto infants' eyes or skin and causing rash, burn, or inflammation.

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: This is a Class II FDA recall for a heating device with documented reports of rupture or leaking during activation that could cause contact injuries including rash, burn, and inflammation. No injuries have been reported, making this a risk-of-harm product without documented harm.

Plain-English summary

Cardinal Health 200, LLC is recalling approximately 2,911,064 units of Infant Heel Warmer (SKU MH00002N), a nonsterile product designed to warm an infant's heel to facilitate blood draws. The warmer is activated by squeezing the pouch, which triggers an exothermic chemical reaction that heats the contents.

The manufacturer has received reports that the pouch may rupture or leak during the activation process. When this occurs, the heated liquid contents can splash onto the infant or into the eyes of the user. Contact with the liquid inside the pouch can cause rash, burn, and inflammation.

A caution statement is being added to remind users to activate the warmer away from the infant's face and their own face. The recalled product has been distributed nationwide to healthcare facilities in all U.S. states and Washington, D.C. All lot numbers are affected by this Class II recall.

The recalled product

Product: Infant Heel Warmer without Attachment Tab, Nonsterile, Active Product SKU MH00002N The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which…
Manufacturer: Cardinal Health 200, LLC
Category: Medical Device — Neonatal Warming Device
Hazard: rupture
burn-injury
rash
eye-splash
Affected units: 2,911,064

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 lots

Distribution

Distributed nationwide across the United States.

The notice also names 47 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Cardinal Health 200, 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.

See all 2 products in this recall →

Same manufacturer · Cardinal Health 200, LLC

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Same hazard · rupture