NovaPlus Infant Heel Warmer — Class II medical device recall Z-2147-2023
Ongoing recall by Cardinal Health 200, LLC, reported 2023-07-26, distributed nationwide. Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regarding the above
| Recall number | Z-2147-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Waukegan, IL, United States |
| Recall initiated | 2023-06-16 |
| Classified | 2023-07-17 |
| Reported by FDA | 2023-07-26 |
| Distributed | Nationwide (US) |
| Quantity | 44,500 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10885380057588, 20885380057585, 50885380057586 |
| Lot numbers | V2S056 |
| Model numbers | V11460-010 |
Product
NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010
Reason for recall
Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regarding the above listed lot of the Novalplus Infant Heel Warmer with tape.
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-2147-2023. 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.