Cardinal Health Tiny Toes — Class II medical device recall Z-0543-2016
Terminated recall by Philips Electronics North America Corporation, reported 2015-12-30. Heel warmers may cause first and second degree burns.
| Recall number | Z-0543-2016 |
|---|---|
| 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 | 2015-11-20 |
| Classified | 2015-12-24 |
| Reported by FDA | 2015-12-30 |
| Terminated | 2017-08-07 |
| Quantity | 7,327,100 individual |
Product
Cardinal Health Tiny Toes; 11470-010T Infant heel warmer
Reason for recall
Heel warmers may cause first and second degree burns.
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-0543-2016. 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.