CooperSurgical, Inc.: Medical Device Recall in 2019 - (Recall #: Z-2364-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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 (when starting from 75 ) in 60 seconds or less. The product is sold in boxes of 6 Infant Transport Mattresses per box. The intended use of the product is to provide warmth during infant transport within the hospital or between hospitals.

Product Classification:

Class II

Date Initiated: July 8, 2019

Date Posted: September 4, 2019

Recall Number: Z-2364-2019

Event ID: 83110

Reason for Recall:

The firm updated the IFU in April 2019 to clarify that use of the TRANSWARMER Mattress with other heat producing devices, such as an incubator, is prohibited and could lead to serious health consequences, such as skin burns. some products do not contain the updated IFU.

Status: Terminated

Product Quantity: 49813

Code Information:

IJ780, IJ782, IJ785, IJ789, IJ794, IJ796, IJ804, IJ807, IJ817, IJ824, IJ832, IJ834, IJ841, IJ853, IJ865, IJ874, IJ878, IJ884, IJ886, IJ892, IJ895, IJ897, IJ900, IJ902, IJ909, IJ917, IJ920, IJ924, IJ933, IJ946, IJ948, IJ957, IJ962, IJ973, IJ976, IJ982, IJ985, IJ999, IK007, IK009, IK015, IK028, IK038, IK041, IK053, IK060, IK066, IK095, IK102, IK107, IK127, IK135, IK147, IK162, IK164, IK171, IK178, IK184, IK201, IK214, IK238, IK252, IK258, IK265, IK270, IK276, IK298, IK318, IK322, IK330, IK332, IK339, IK353, IK361, IK378, IK384, & IK390

Distribution Pattern:

Worldwide Distribution - US Nationwide in all 50 states. International distribution to Australia, Brazil, Canada, Ecuador, Germany, Gibraltar, India, Ireland, Kuwait, Macedonia, New Zealand, Oman, Poland, Puerto Rico, Qatar, Romania, Saudi Arabia, South Korea, Switzerland, United Arab Emirates, & United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated