CooperSurgical TransWarmer Infant Transport Mattress with WarmGel P/N… — Class II medical device recall Z-1397-2015
Terminated recall by CooperSurgical, Inc., reported 2015-04-15, distributed nationwide. Trans Warmer Infant and Transport Mattress not labeled with exp.date may not meet specification
| Recall number | Z-1397-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2013-05-01 |
| Classified | 2015-04-07 |
| Reported by FDA | 2015-04-15 |
| Terminated | 2016-06-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BH, BM, CA, CO, DE, GB, HU, ID, KW, LV, MX, MY, NZ, SA, TR |
| Quantity | 4,807,566 |
| Reason classes | labeling |
Product
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
Reason for recall
Trans Warmer Infant and Transport Mattress not labeled with exp.date may not meet specification
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1397-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.