BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR — Class II medical device recall Z-0488-2018
Terminated recall by C.R. Bard, Inc., reported 2018-02-07, distributed in FL. The possibility exists that use of the Uros Automated Urine Output and Temperature Monitor may lead to the los
| Recall number | Z-0488-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | C.R. Bard, Inc., Covington, GA, United States |
| Recall initiated | 2017-09-29 |
| Classified | 2018-01-29 |
| Reported by FDA | 2018-02-07 |
| Terminated | 2021-07-07 |
| Distributed | FL |
| Quantity | 2 units |
| Model numbers | BK10001M |
Product
BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M The Uros(TM) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature.
Reason for recall
The possibility exists that use of the Uros Automated Urine Output and Temperature Monitor may lead to the loss of urine output measurement data and/or urine output measurement inaccuracies resulting in an impact on clinical treatment decisions.
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-0488-2018. 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.