CooperSurgical TransWarmer Infant Transport Mattress with… recallZ-1397-2015 · CooperSurgical, Inc. · initiated May 1, 2013

Class II Terminated All recalls posted in April 2015

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from CooperSurgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Trans Warmer Infant and Transport Mattress not labeled with exp.date may not meet specification

FDA root cause category: Package design/selection

What the company is doing

CooperSurgical sent a formal recall notification letter dated April 4, 2015 to all affected customers. The letter identified the product problem and the action needed to be taken by the customer. CooperSurgical notified consignees affected by this recall via Fedex with confirmed delivery receipt. The letter identified the affected product and detailed the necessary actions to be taken by customers who carried the affected lots in their inventory. CooperSurigcal will replace any of the affected products that customers had on hand. CooperSurgical provided further instruction on the disposition of the product at the time of replacement. Contact CooperSurgical at 203 601 5200 Ext. 3100 if you have questions. Previously CooperSurgical notified consignees affected by this recall on 5/1/13.

Recall details

Recall number: Z-1397-2015
Recall class: Class II
Status: Terminated
Initiated by the company: May 1, 2013
Posted by the FDA: Apr 7, 2015
Recalling firm: CooperSurgical, Inc.
Quantity: 4,807,566
Product code: IMD
FDA submissions: K934631
Distribution: Worldwide Distribution - US Nationwide - in the countries of:ARGENTINA, AUSTRALIA,BAHRAIN, ,BERMUDA,CANADA,COLOMBIA ,ENGLAND, GERMANY,HUNGARY,INDONESIA, KUWAIT,LATVIA,LIBYA,MALAYSIA MEXICO,NEW ZEALAND,SAUDI ARABIA. TURKEY, UNITED ARAB EMIRATES

Product description

CooperSurgical TransWarmer Infant Transport Mattress with WarmGel P/N 20421 Private label: NovaPlus TransWarmer Infant Heat Therapy Mattress with WarmGel. P/N V6390 Provides warmth during transport of infant within the hospital or between hospitals

Code information (models, lots, serial numbers)

Product with no lot/ expiration date on the product label

Other devices under the same FDA submission

1 device cleared under K934631 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

TRANSWARMER INFANT TRANSPORT MATTRESS 20421
Coopersurgical, Inc. · Pack, Hot Or Cold, Disposable
6 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.

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