FDA warns firms for marketing unauthorized devices, shoddy complaint handling
The US Food and Drug Administration (FDA) recently warned a distributor and medical device maker for marketing continuous positive airway pressure (CPAP) machines and related software for treating sleep apnea without securing proper marketing authorization and for inadequate complaint handling. The agency also warned a device maker for misclassifying its products as exempt from premarket notification requirements.
All three letters were posted on the agency’s website on 30 June.
BMC Medical
FDA posted a warning letter to BMC Medical Co., in Beijing, China, the specification developer and manufacturer of various ventilator devices imported into the US by 3B Medical. The warning letter followed an inspection of 3B Medical’s Dublin, OH facility in December.
The warning letter indicates that BMC made significant changes to its Auto-Adjusting Positive Airway Pressure (Auto-CPAP or APAP) ventilator devices intended for treating obstructive sleep apnea in adults without submitting a new 510(k).
“FDA concluded that BMC made significant software and hardware changes to its Luna G3 APAP device—including new event-recognition algorithms and changes to the sound-abatement system—that required a new premarket submission before commercial distribution. As a result, FDA stated the devices were adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act,” FDA wrote, noting that the changes yielded a new model marketed as G3X APAP.
FDA also noted that the company failed to submit a Report of Correction or Removal to the agency after alerting 3B Medical of a correction involving a firmware update intended to correct an issue that could cause the Luna G3 APAP device to unexpectedly shut down during use.
3B Medical
FDA posted a separate warning letter to 3B Medical, a distributor in Dublin, OH, for multiple quality system and good manufacturing practice issues. The firm manufactures iCodeConnect, a cloud-based software device, intended to be used with a CPAP and APAP ventilator devices.
The company also imports and manages the complaint handling for APAP and Bilevel Positive Airway Pressure (BPAP) ventilator devices from BMC Medical, including the firm’s Luna G3 APAP, G3X APAP, Luna G3 BPAP, Luna G3 30VT, and Luna G2 APAP devices.
FDA said the APAP devices distributed by the company as Luna G3 APAP and Luna G3X APAP are considered adulterated and misbranded as they lack an approved premarket approval (PMA) application and have been significantly modified from the devices most recent 510(k) notifications.
FDA inspectors also found the company failed to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.
Out of the eleven complaint records reviewed, seven were cancelled despite they’re meeting the definition of a complaint under the company’s definition of a complaint.
From 28 August 2024 to 21 November 2025, the firm cancelled complaints regarding various issues. These included pressure delivery problems, shutdowns, and electronic and software failures related to its Luna G3 APAP/BPAP devices. Additionally, complaints concerning abnormal pressure readings, low oxygen output, and persistent red-light alarms for its Stratus oxygen concentrators were also cancelled. Other complaints involved unusual smells from its Phoenix 5L oxygen concentrators and durability issues with its Rio masks.
FDA criticized the company for not establishing and maintaining procedures to validate the device design. For example, after acquiring the iCodeConnect software on 8 May 2025, the firm accepted an outdated 2016 version of the Risk Management Report instead of the updated version specified in Appendix A of its “Software Copyright Transfer Contract.” The 2016 version did not include an assessment of the risk acceptability for post-production design changes to the iCodeConnect software that occurred between 2018 and 2025. This issue impacted four Luna devices and one G3 X APAP device.
AseptiKits
FDA issued a warning letter to AseptiKits LLC in North Salt Lake, UT for violations related to marketing its PALA YourTears, ALAdroop, SyrilKit, and VitrALA devices without obtaining the necessary 510(k) or PMA approval. The company manufactures convenience kits for sterile solutions and drops without the need for a clean room.
The company asserted that its convenience kits are exempt from premarket notification requirements and fall under product code NEP for pharmacy compounding systems; however, FDA disagreed with this assessment.
According to information on the company’s website, three models of PALA YourTears are closed system bags that come with filters and syringes, designed for the sterile preparation of serum. The ALAdrop is another closed system bag that also includes a syringe and filter, intended for the sterile preparation of eye drops. The SyrilKit contains 20 syringes with filters specifically designed for the sterile preparation of solutions. Finally, the VitrALA is a closed system bag that includes filters and syringes, intended for priming and measuring drug products.
FDA said that “the subject devices are syringes, filters and closed system transfer devices (bag). These devices fall under various product codes such as FMF (for syringe) and ONB (for closed system transfer devices). These product codes are for class II, non-exempt devices. The products, which contain syringes and containers for the drug, are not pharmacy compounding systems. Accordingly, the subject products are not exempt from premarket notification under 21 CFR § 880.5440(b).”
The agency requested that the company immediately cease any activities resulting in the misbranding or adulteration of its devices, particularly the commercial distribution for these products.
