FDA Device recall Z-0508-2022
Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T
- FDA Device
- Class II
- ongoing
- Published 2022-01-26
On 2022-01-26 the FDA classified a Class II recall of Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T by Philips North America, citing after the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot b….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0508-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-11-29 |
| Published | 2022-01-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips North America |
| Distribution | US |
Product
Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T
Reason
After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.
Identifiers
| code_info | All units are impacted |
|---|
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-0508-2022%22
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