FDA Device recall Z-2147-2023
NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010
- FDA Device
- Class II
- ongoing
- Published 2023-07-26
On 2023-07-26 the FDA classified a Class II recall of NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010 by Cardinal Health 200, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2147-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-16 |
| Published | 2023-07-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cardinal Health 200 |
| Distribution | US |
Product
NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010
Reason
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.
Identifiers
| code_info | UDI/DI (Case) 50885380057586, (Box) 20885380057585, (EA) 10885380057588, Lot Number V2S056 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2147-2023%22
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