Use cautionMedical device recall · FDA · Published July 8, 2019
CooperSurgical TransWarmer Infant Mattress Recall: Risk of Skin Burns from Incubator Use
CooperSurgical recalls TransWarmer Warming Infant Transport Mattress Model 20421 due to risk of skin burns if used with incubators. Some units lack updated safety instructions.
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.
Take action
Contact the company
📍Recalling firmCooperSurgical, Inc.95 Corporate Dr · Trumbull, CT 06611-1350
“CooperSurgical TransWarmer Infant Mattress Recall: Risk of Skin Burns from Incubator Use.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67478-coopersurgical-transwarmer-infant-mattress-recall-risk-of-skin-burns-from. Based on FDA recall #Z-2364-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2364-2019%22&limit=1).
CooperSurgical, Inc. recalled the TransWarmer Warming Infant Transport Mattress, Model no. 20421, because some units lack an updated instruction manual that prohibits use with other heat-producing devices, which could cause skin burns, according to the FDA. The agency announced the recall on July 8, 2019.
How to tell if you have it
Brand: CooperSurgical
Product: TransWarmer Warming Infant Transport Mattress
The firm updated the instruction manual in April 2019 to clarify that using 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 instruction manual.
Context
GovInfoNow's records show CooperSurgical, Inc. has 37 other recalls on record since October 6, 2017. Other recent recalls of similar products include INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP (August 11, 2026), Endosee System Convenience Kit (June 11, 2025), and K-Systems T47 Warming Plate (November 15, 2024).
How to tell if you have this one
Check for the model number 20421 on the product. The recall applies to units sold with older safety instructions that don't include the April 2019 update.
Brand
CooperSurgical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Safety Instructions
Look for the updated safety instructions from April 2019 that prohibit using the mattress with incubators or other heat sources.
Stop Using with Incubators
If you have the mattress with older instructions, do not use it with incubators or other heat-producing devices.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2364-2019 (July 8, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2364-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.