Devices & drugs
3B Medical labeled a sleep device for reuse it was never cleared for
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.
Sources
Every statement above is taken from these public records.
These notes paraphrase and quote one public FDA warning letter. They are not legal advice. Redaction marks such as (b)(4) are FDA’s.