eValueMed Infant Transport Mattress 301-1015 — Class II medical device recall Z-1317-2016
Terminated recall by Philips Electronics North America Corporation, reported 2016-04-13, distributed nationwide. eValueMed Infant Heel Warmers and eValueMed Infant Transport Mattresses bear no expiration date, nor any warni
| Recall number | Z-1317-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Electronics North America Corporation, Andover, MA, United States |
| Recall initiated | 2016-02-10 |
| Classified | 2016-04-04 |
| Reported by FDA | 2016-04-13 |
| Terminated | 2017-08-01 |
| Distributed | Nationwide (US) |
| Quantity | 539.156 |
Product
eValueMed Infant Transport Mattress 301-1015, Distributed by Tri-anima A disposable heel warmer for use when circulation needs to be stimulated in the infant heel in order for blood sampling to occur
Reason for recall
eValueMed Infant Heel Warmers and eValueMed Infant Transport Mattresses bear no expiration date, nor any warning that product used beyond its expected shelf life may warm to temperature above its 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-1317-2016. 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.