Agency classClass IIOur severity:High FDA (Devices)·Z-2364-2019·Announced 2019-09-04

CooperSurgical Recalls TransWarmer Infant Mattresses Due to Burn Risk

CooperSurgical is recalling TransWarmer Warming Infant Transport Mattresses because some units lack updated instructions prohibiting use with other heat devices, which could cause skin 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 serious injury (skin burns) to vulnerable infants, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

CooperSurgical, Inc. is recalling the TransWarmer Warming Infant Transport Mattress, Model no. 20421. The product is a gel-filled, disposable mattress intended to provide warmth during infant transport within or between hospitals. The recall involves 49,813 units distributed nationwide in the United States and internationally to multiple countries.

The recall was initiated because some products do not contain the updated Instructions for Use (IFU) issued in April 2019. The updated IFU clarifies that using the TransWarmer Mattress with other heat-producing devices, such as an incubator, is prohibited. The firm notes that such combined use could lead to serious health consequences, including skin burns.

Healthcare facilities and consumers should stop using the affected units immediately. Users should check the lot codes on their products against the list of affected codes provided by the FDA. If a unit is affected, it should be returned to the distributor or manufacturer for replacement or refund.

The recalled product

Product: TransWarmer Warming Infant Transport Mattress, Model no. 20421 Product Usage: The TransWarmer¿ Warming Infant Transport Mattress is gel-filled, disposable mattress that provides heat for up to two hours when cold stress is a concern. The patented WarmGel heats up to 104…
Manufacturer: CooperSurgical, Inc.
Category: Medical Device — Infant Care
Hazard: burn-injury
mis-labeling
Affected units: 49,813

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 (20)

IJ780
IJ782
IJ785
IJ789
IJ794
IJ796
IJ804
IJ807
IJ817
IJ824
IJ832
IJ834
IJ841
IJ853
IJ865
IJ874
IJ878
IJ884
IJ886
IJ892

Distribution

Distributed nationwide across the United States.

Same manufacturer · CooperSurgical, Inc.

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