FDA Device recall Z-0153-2023
CritiCool, thermoregulation device
- FDA Device
- Class II
- ongoing
- Published 2022-11-09
On 2022-11-09 the FDA classified a Class II recall of CritiCool, thermoregulation device by Belmont Instrument, citing premature pump failure may lead to the device displaying a HALT 4 error, from which the device cannot recover even after device reboot. The issue may potentially lead to delayed t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0153-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-07-20 |
| Published | 2022-11-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Belmont Instrument |
| Distribution | US |
Product
CritiCool, thermoregulation device
Reason
Premature pump failure may lead to the device displaying a HALT 4 error, from which the device cannot recover even after device reboot. The issue may potentially lead to delayed treatment and a failure to deliver the prescribed thermoregulation therapy. To date, the firm has received one report of death potentially related to this issue.
Identifiers
| code_info | UDI-DI: 07290107581110 Serial Numbers: 9978580900011 99110698100043 99110698100044 9963715800012 9982077400003 99710405…UDI-DI: 07290107581110 Serial Numbers: 9978580900011 99110698100043 99110698100044 9963715800012 9982077400003 9971040500004 9982294100006 9964294500006 9963715800008 9964294500007 9978580900008 9978580900009 9999186600019 99110008800035 99110008800036 99109321700020 99109321700026 99110992900020 99100663300011 99100663300014 99101637500005 99110698100048 9966227400007 9966227400012 9989990200008 9995915300007 9995915300014 9966227400008 9966227400011 9969231000003 9969231000004 9969231000005 9969570100004 9969570100014 9969570100018 99108208900030 99109321700010 9989990200012 99110992900011 9974072400005 99102316800013 9974085100011 9995355700003 99108208900023 99108208900025 996622740007 9969570100016 99104180900007 99107291500013 99107291500016 9983874900002 99108208900022 99109321700004 9978471200014 99100663300013 99100663300023 9995355500001 9995355500001 9995355500003 9995355500003 9996480200001 99104183000019 99104183000021 99110698100028 99110698100029 9982315400005 9982315400 |
|---|
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-0153-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.