The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1299-2015·Announced 2015-03-25

Fisher Brand Infant Heel Warmers Recalled for Burn Risk

CooperSurgical is recalling Fisher Brand Gel and Liquid Infant Heel Warmers because products without expiration dates pose 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 'High' severity criteria for theoretical or unreported harm.

Plain-English summary

CooperSurgical, Inc. is recalling Fisher Brand Gel Infant Heel Gel Warmers (Cat. No. 22-024647) and Fisher Brand Liquid Infant Heel Warmer (Cat. No. 22-024646). These medical devices are used to provide gentle heat to increase blood flow and enhance infant blood sample collection. The recall involves 8,865,584 units that were distributed nationwide in the United States and internationally to Australia, Bahrain, Bermuda, Canada, France, Latvia, Libya, Mexico, New Zealand, Qatar, Saudi Arabia, Singapore, and the United Kingdom.

The recall is being conducted because products without an expiration date have the remote potential for minor burn. The source text does not specify a lot number or expiration date for the affected units, noting only that they lack these identifiers. No illnesses or injuries have been reported in the source text.

Healthcare facilities and consumers should stop using these products immediately. CooperSurgical, Inc. is the recalling firm responsible for managing the recall. Users should contact the manufacturer for instructions on how to return or dispose of the affected units.

The recalled product

Product
Fisher Brand Gel Infant Heel Gel Warmers, Cat. No.: 22-024647 Fisher Brand Liquid Infant Heel Warmer, Cat. No: 22-024646 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
8,865,584

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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