CooperSurgical Recalls MediChoice Infant Heel Warmers for Burn Risk
CooperSurgical is recalling MediChoice Infant Heel Warmers 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 (potential for minor burns) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
CooperSurgical, Inc. is recalling MediChoice WarmGel Infant Heel Warmer (Item # 1643069911) and MediChoice Liquid Infant Heel Warmer (Item # 1643069912). These single-use, disposable devices are distributed by Owens & Minor and are used 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 identified as those lacking an expiration date and lot number.
The recall involves 18,696,754 units 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. Consumers and healthcare facilities should stop using these products and contact the distributor or manufacturer for instructions.
The recalled product
- Product
- MediChoice WarmGel Infant Heel Warmer, Item # 1643069911 MediChoice Liquid Infant Heel Warmer, Item # 1643069912 Single Use and Disposable. Distributed by: Owens & Minor. 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
- 18,696,754
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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