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All product recalls associated with Sutter Medizintechnik GmbH Tullastr. 87 Freiburg Im Breisgau Germany.
Total Recalls
1000
Past Year
423
Class I (Serious)
54
Most Recent
Jan 2026
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
The label on the cardbox and the blister show the correct symbols for sterilization using irradiation and storage at 5 C to 40 C, the package insert (IFU) is labelled incorrectly. It shows the symbol for sterilization using Ethylene Oxide with the description for sterilization using irradiation.
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
CARESCAPE ONE may not provide visual and audible alarms for Ventricular Fibrillation (V Fib), if V Fib occurs at the time CARESCAPE ONE is docked to a CARESCAPE B450/B650/B850 host monitor.