FDA WARNING_LETTER - 3B Medical, Inc. dba Reach Health, Inc. - December 10, 2025

3B Medical, Inc., doing business as Reach Health, Inc., received a formal warning from the FDA following an inspection of its Dublin, Ohio, facility from December 1 to December 10, 2025. The agency determined that the company’s quality management processes for its medical devices—including software, ventilators, and oxygen concentrators—failed to meet federal standards set by the Federal Food, Drug, and Cosmetic Act and the Quality System regulation.

The primary violations involve significant failures in complaint handling and safety reporting. The firm frequently misclassified product complaints as simple inquiries and failed to investigate reports of serious health incidents, such as patients experiencing choking or shortness of breath. These issues were compounded by a backlog of thousands of unprocessed complaints and inadequate staffing. Additionally, the FDA found that the company marketed certain breathing devices for multi-patient use despite only having clearance for single-patient use, creating a risk of cross-contamination. Other issues included failing to report a product correction for mislabeled nasal masks and shipping expired components without proper corrective actions.

The company is required to submit a written response within 15 business days detailing the steps taken to address these systemic failures. This plan must include a clear timetable for implementation and evidence of improvements. The FDA noted that all future actions must align with the updated Quality Management System Regulation (QMSR) that went into effect in February 2026. Continued non-compliance could lead to severe consequences, including product seizures or legal injunctions.