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All product recalls associated with Biosense Webster, Inc..
Total Recalls
1000
Past Year
295
Class I (Serious)
116
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.
Increased complaints regarding catheters with leaks and flow obstruction.
False Positive results may be obtained with the identified lot of list 3A60-16 when using a negative patient sample or a negative control.
The product issue is that the value sheet for the Clinical Chemistry Bilirubin Calibrator, lot #20881M100 calibrator value sheet, has the calibrator values transposed for the Total Bilirubin Assay LN 7D60, Total Bilirubin Assay LN 8G62, and Neonatal Bilirubin Assay LN 9D88.