Sensica Urine Output System — Class II medical device recall Z-0554-2024
Ongoing recall by C.R. Bard Inc, reported 2023-12-20, distributed nationwide. BD (C.R. Bard) has received user complaints reporting that when the device was connected to WiFi/Internet, the
| Recall number | Z-0554-2024 |
|---|---|
| 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 | 2023-11-15 |
| Classified | 2023-12-14 |
| Reported by FDA | 2023-12-20 |
| Distributed | Nationwide (US) |
| Quantity | 148 units |
| UPC / GTIN / UDI-DI | 00801741215773 |
| Serial numbers | BMFPRMYS009, BMFQRMS244, BMFQRMS246, BMFQRMS248, BMFQRMS250, BMFQRMS272, BMFQRMS276, BMFQRMS286, BMFQRMS293, BMFQRMS294, BMFRRMS646, BMFRRMS647, BMFSRMSH78, BMFSRMSH79, BMFSRMSH80, BMFSRMSH81, BMFSRMSH82, BMFSRMSH83, BMFSRMSH93, BMFSRMSH94, BMFSRMSH95, BMFSRMSH97, BMFSRMSH98, BMFSRMSH99, BMFSRMSJ00 and 123 more |
| Model numbers | SCCS1002 |
Product
Sensica Urine Output System, Catalog Number SCCS1002
Reason for recall
BD (C.R. Bard) has received user complaints reporting that when the device was connected to WiFi/Internet, the time displayed on the Sensica device changed during a patient monitoring session which resulted in 1) incorrect time displayed on the monitoring screen, 2) incorrect hour block timestamps on the monitoring screen, 3) incorrect hour timestamps on data screens, and 4) incorrect catheter use time.
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-0554-2024. 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.