CooperSurgical, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1397-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: May 1, 2013

Date Posted: April 15, 2015

Recall Number: Z-1397-2015

Event ID: 70368

Reason for Recall:

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

Status: Terminated

Product Quantity: 4,807,566

Code Information:

Product with no lot/ expiration date on the product label

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated