The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2147-2015·Announced 2015-07-29

CooperSurgical Recalls Infant Heel Warmers for Lack of FDA Clearance

CooperSurgical is recalling infant heel warmers sold under CooperSurgical and Fisher brands because they were marketed without FDA 510(k) clearance.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as a regulatory compliance failure (marketing without 510(k) clearance) rather than a specific physical defect or reported injury, aligning with the 'Moderate' criteria for voluntary or compliance-driven recalls without reported harm.

Plain-English summary

CooperSurgical, Inc. is recalling Infant Heel Warmers and Infant Gel Warmers sold under the CooperSurgical and Fisher brand names. The specific products involved include the WarmGel Infant Heel Warmer, Liquid Infant Heel Warmer, FisherBrand Gel Infant Heel Warmer, and FisherBrand Liquid Infant Heel Warmer, all sold in boxes of 100. The recall covers all lot numbers.

The recall was initiated because the products were marketed without a 510(k) clearance from the U.S. Food and Drug Administration. A 510(k) is a premarket submission process that provides the FDA with evidence that a device is at least as safe and effective as a legally marketed device. The agency classification for this recall is Class II.

The products were distributed worldwide, including in the United States, Australia, Bermuda, Ecuador, France, New Zealand, Saudi Arabia, and the United Kingdom. The total quantity of units recalled is 6,344,700. Consumers and healthcare facilities should stop using these products and contact the recalling firm for instructions on return or replacement.

The recalled product

Product
Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fisher brand as follows : CooperSurgical PN 20418 WARMGEL INFANT HEEL WARMER - PRISM BOX OF 100; PN 24401 LIQUID INFANT HEEL WARMER - PRISM BOX OF 100; and Fisher Brand. PN 24647…
Manufacturer
CooperSurgical, Inc.
Category
Medical Device — Infant Care
Hazard
Affected units
6,344,700

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 lot numbers

Distribution

Distributed nationwide across the United States.

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