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All product recalls associated with Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc..
Total Recalls
1000
Past Year
593
Class I (Serious)
65
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.
Endocare received a report of a patient death that occurred during a prostate cryoablation procedure. An autopsy attributed the cause of death to an air embolism. The safety notice for the cryoprobes was issued to refocus attention on the Indications and Safety Review included with the Physician Training Materials and to reinforce additional safety information.
The product was breaking during use.
Potential for Internal Sound Amplifier to malfunction which could delay treatment.