CritiCool — Class II medical device recall Z-0153-2023
Ongoing recall by Belmont Instrument Corporation, reported 2022-11-09, distributed nationwide. Premature pump failure may lead to the device displaying a HALT 4 error, from which the device cannot recover
| Recall number | Z-0153-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Belmont Instrument Corporation, Billerica, MA, United States |
| Recall initiated | 2021-07-20 |
| Classified | 2022-10-31 |
| Reported by FDA | 2022-11-09 |
| Distributed | Nationwide (US) |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00996622740007, 07290107581110, 09910324500012, 09954452900016, 09964294500015, 09966227400003, 09966227400010, 09969414800006, 09969414800013, 09969414800020, 09969570100002, 09969570100019, 09969570200009, 09969570200016, 09970259900004, 09971040500007, 09971040500014, 09971473300007, 09971473300014, 09973538500001, 09973538600008, 09973538600015, 09974072400017, 09974085100003, 09975437700001 and 75 more |
| Serial numbers | 06-5086, 99100663300002, 99100663300003, 99100663300004, 99100663300005, 99100663300007, 99100663300008, 99100663300009, 99100663300010, 99100663300011, 99100663300012, 99100663300013, 99100663300014, 99100663300015, 99100663300016, 99100663300018, 99100663300019, 99100663300020, 99100663300021, 99100663300022, 99100663300023, 99100663300024, 99100663300025, 99100663300026, 99100663300027 and 475 more |
Product
CritiCool, thermoregulation device
Reason for recall
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.
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-0153-2023. 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.