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All product recalls associated with Edwards Lifesciences Research Medical, Inc..
Total Recalls
1000
Past Year
893
Class I (Serious)
124
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.
Balloon catheters were spontaneously rupturing during use.
The recall involves the Buderus GB312 gas-fired, floor standing condensing boilers. Model numbers included in this recall are: 312/90, 312/120, 312/160, 312/200, 312/240 and 312/280. "BUDERUS GB312" is printed on the front of the boiler. The boilers are blue, approximately 60 inches high and between 39 and 55 inches wide.
The pediatric tracheal tubes used in these kits were manufactured with an internal diameter smaller than indicated in the label, which could result in an inability to remove secretions and cause partial or complete obstruction of the airway.