The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1301-2015·Announced 2015-03-25

CooperSurgical Recalls NovaPlus Infant Heel Warmers Due to Burn Risk

CooperSurgical is recalling NovaPlus infant heel warmers because products without expiration dates may cause 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 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 explicitly states the hazard is a 'remote potential for minor burn,' which aligns with the rubric for moderate severity involving low-risk contamination or minor injury potential without reported serious harm.

Plain-English summary

CooperSurgical, Inc. is recalling NovaPlus Brand Warm Gel Infant Heel Gel Warmer (Item # V6391) and NovaPlus Brand Liquid Heal Warmer (Item # V6393). These single-use, disposable medical devices are intended to provide gentle heat to increase blood flow and enhance infant blood sample collection.

The recall is being conducted because products without an expiration date have the remote potential for minor burn. The affected units are distributed worldwide, including in the United States, Australia, Bahrain, Bermuda, Canada, France, Latvia, Libya, Mexico, New Zealand, Qatar, Saudi Arabia, Singapore, and the United Kingdom.

Consumers and healthcare facilities should stop using these products and contact CooperSurgical, Inc. for further instructions or a refund.

The recalled product

Product
NovaPlus Brand Warm Gel Infant Heel Gel Warmer, Item # V6391 NovaPlus Brand Liquid Heal Warmer. Item #V6393 Single Use and Disposable 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
4,938,266

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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