Class II — CooperSurgical, Inc.
| Recalling firm | COOPERSURGICAL, INC. |
|---|---|
| Registered facility | View this company's 6 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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 (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. |
| Quantity | 49813 |
| 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 Arabia, South Korea, Switzerland, United Arab Emirates, & United Kingdom. |
| Initiated | 2019-07-08 |
| Classified | 2019-08-23 |
| Terminated | 2020-05-28 |
| Recall number | Z-2364-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — CooperSurgical, Inc. (Z-2364-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83110/
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