CritiCore Automated Urine Output and Temperature Monitor — Class II medical device recall Z-2243-2018
Ongoing recall by C.R. Bard, Inc., reported 2018-06-27, distributed in AR, AZ, CA, FL, GA, HI, IN, KS…. Issues identified with the monitor including urine output measurement errors, temperature measurement errors a
| Recall number | Z-2243-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | C.R. Bard, Inc., Covington, GA, United States |
| Recall initiated | 2017-11-10 |
| Classified | 2018-06-15 |
| Reported by FDA | 2018-06-27 |
| Distributed | AR, AZ, CA, FL, GA, HI, IN, KS, LA, MD, MN, MO, MS, NC, NJ, OH, OK, TN, TX, VA, WA, WI, WY |
Product
CritiCore Automated Urine Output and Temperature Monitor
Reason for recall
Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms.
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-2243-2018. 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.