The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1298-2015·Announced 2015-03-25

CooperSurgical Infant Heel Gel Warmers Recalled for Burn Risk

CooperSurgical is recalling Infant Heel Gel Warmers and The Infant Heel Warmer because products without expiration dates have a remote potential for minor burns.

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 (burn injury) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

CooperSurgical, Inc. is recalling its Infant Heel Gel Warmers (P/N 20418) and The Infant Heel Warmer (P/N 2440). These devices are used to provide gentle heat to increase blood flow and enhance infant blood sample collection. The recall involves approximately 20,398,889 units distributed worldwide, including the United States, Australia, Bahrain, Bermuda, Canada, France, Latvia, Libya, Mexico, New Zealand, Qatar, Saudi Arabia, Singapore, and the United Kingdom.

The reason for the recall is that products without an expiration date have the remote potential for minor burns. The affected products are identified as those without an expiration date and lot number.

Consumers and healthcare facilities should stop using these devices and contact CooperSurgical, Inc. for instructions on how to return or dispose of the products.

The recalled product

Product
CooperSurgical Infant Heel Gel Warmers, P/N 20418 CooperSurgical The Infant Heal Warmer, P/N 2440 To provide gentle heat to increase blood flow and enhance infant blood sample collection
Manufacturer
CooperSurgical, Inc.
Category
Medical Device — Infant Care
Hazard
Affected units
20,398,889

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)

  • Products without an expiration date and lot number

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by CooperSurgical, Inc. 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 4 products in this recall →

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