C.R. Bard CritiCore Monitor Recall: Urine Output Measurement Fluctuations
C.R. Bard recalls CritiCore monitors with serial numbers listed that may have urine output and temperature measurement fluctuations, causing potential inaccuracies in patient monitoring.
Lower-risk recall
BMD has identified that some lots of CritiCore(R) monitors may experience failures involving urine output volume measurement fluctuations, core bladder temperature measurement fluctuations and alarm errors.
Contact the company
What happened, in plain English
C.R. Bard is recalling some CritiCore automated urine output and temperature monitors due to possible measurement fluctuations. This could lead to inaccurate readings, which might affect patient care decisions. Read more at govinfonow.com/recall/72565-c-r-bard-criticore-monitor-recall-urine-output-measurement-fluctuations.
Source Summary by GovInfoNow · govinfonow.com/recall/72565-c-r-bard-criticore-monitor-recall-urine-output-measurement-fluctuations · Updated September 1, 2026 · FDA enforcement record: FDA #Z-0565-2018
Cite this page
“C.R. Bard CritiCore Monitor Recall: Urine Output Measurement Fluctuations.” GovInfoNow, updated September 1, 2026. https://govinfonow.com/recall/72565-c-r-bard-criticore-monitor-recall-urine-output-measurement-fluctuations. Based on FDA recall #Z-0565-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0565-2018%22&limit=1).
Why it’s dangerous
The monitors may experience fluctuations in urine output volume measurements and core bladder temperature readings, which could lead to inaccurate patient monitoring data. This might cause healthcare providers to make incorrect clinical decisions based on faulty information.
Who’s affected
Healthcare providers using the CritiCore monitor for urine output and temperature monitoring in patients are likely affected. Patients using the device for critical care monitoring are at risk if the device provides inaccurate readings.
How to tell if you have this one
Check if your CritiCore monitor has a serial number starting with DYZ, DYA, DYB, or DYB followed by specific digits as listed in the recall notice. The product is sold for use in hospitals and critical care settings.
- Brand
C.R. Bard- Category
Medical device
What to do — step by step
Check Serial Number
Verify your monitor's serial number against the list of affected numbers provided in the recall notice.
How this recall unfolded
Recall timeline
FDA terminated this recall 3.9 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0565-2018 (November 10, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0565-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 1, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.