FDA Device recall Z-0509-2022
Medichoice Infant Heel Warmer, Reference # 989805643721 1079906
- FDA Device
- Class II
- ongoing
- Published 2022-01-26
On 2022-01-26 the FDA classified a Class II recall of Medichoice Infant Heel Warmer, Reference # 989805643721 1079906 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-0509-2022 |
| 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
Medichoice Infant Heel Warmer, Reference # 989805643721 1079906
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-0509-2022%22
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