Devices & drugs
Warning letter 725108, 3B Medical
FDA told 3B Medical, doing business as Reach Health, that a cloud program used with sleep-apnea ventilators was being run on a 2016 risk file, that complaints of choking and shortness of breath were closed without asking whether anyone was hurt, and that two APAP devices were being labeled for multi-patient reuse they were never cleared for.
The Dublin, Ohio inspection ran December 1–10, 2025. The firm makes iCodeConnect, a cloud software device used with CPAP and auto-adjusting PAP machines, and imports Luna ventilators from BMC Medical in Beijing. FDA reviewed cancelled “complaints” and “inquiries” that still met the firm’s own definition — pressure that pulsated, a machine that stopped after a drop, data that would not upload. Tickets about a patient who “chokes her out,” a burst of hard airflow that left a user short of breath, and a device that “woke [the patient] short of air” had no follow-up on medical harm and no medical-device report.
On the product lane: the last 510(k) for the APAP devices, K153387, cleared them in 2016 for single-patient use. User manuals on the firm’s site as of May 19, 2026, FDA writes, say “multi-patient re-use in the hospital/institutional environment.” That, the letter says, is a major change in intended use — cross-contamination risk the cleared labeling never covered — and needs a new 510(k).
A 2023 field notice on mislabeled Rio II nasal-pillow boxes was never filed as a correction-or-removal report under 21 CFR 806. After buying iCodeConnect on May 8, 2025, the firm accepted a risk-management report dated August 13, 2016, and did not assess later software changes, including a 2024 refactor and added ventilator models through July 2025.
fda.gov — 3B Medical, Inc. dba Reach Health, Inc. — 725108 — 05/20/2026
These notes paraphrase and quote one public FDA warning letter. They are not legal advice. A warning letter is an administrative notice, not a court judgment. Redaction marks such as (b)(4) are FDA’s.