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.
What this means for you
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.
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