Luna G3 BPAP System LG3800-30VT — Class I recall for Targeted VT pressure-recording error
Luna G3 BPAP System for treatment of adult obstructive sleep apnea. Match the individual serial number against FDA Code Information; model alone does not establish inclusion.
Manually maintained record
An editor supplied or changed this record. These edits have not been verified by the agency. Last edited: 2026-11-13T04:04:37.859Z. No official verification is recorded.
Reported risk
When Targeted VT is enabled, the configured IPAP value is recorded and transmitted instead of the actual delivered inspiratory pressure. This does not establish that the delivered pressure itself is incorrect. FDA classification: Class I; cause: device design. Incident and injury counts are not disclosed in this record.
What should I do if I have this product?
Immediately discontinue Targeted VT if enabled on affected devices. Remove affected devices from clinical service and segregate them to prevent further use; use unaffected PAP devices for patient support. Complete the customer response form included with the notification letter to receive the React Health firmware correction, then update as directed. Customer notifications began October 9, 2026.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
The product description and identifiers below were supplied or edited by a person. Confirm them with the agency notice or the firm before relying on a match; missing information does not establish that your product is unaffected.
Which lot codes, UPCs or models are affected?
UDI-DI 06948538365731. Individual affected serial numbers are listed in the official FDA notice. Recall Event 100001; Recall Z-0409-2027.
- Agency record number
- Z-0409-2027
- Affected products
- Luna G3 BPAP System for treatment of adult obstructive sleep apnea. Match the individual serial number against FDA Code Information; model alone does not establish inclusion.
- Company
- 3B Medical, Inc.
- Quantity
- 12,672 units
- Distribution
- United States nationwide including Puerto Rico; no distribution outside the United States.
- Models
- LG3800-30VT
- Contact
- FDA-listed company contact: George Koos, 1-863-2266285.
Notice details
FDA posted this Class I recall on November 12, 2026. The firm initiated the action on October 8, 2026 and began notifying customers on October 9, 2026. FDA status at review: Open, Classified. Official source checked November 13, 2026 UTC: FDA CDRH cfRES record 223102, Event 100001, Z-0409-2027. The official notice contains a long affected-serial-number list; consult that list and the notification letter to identify an individual device. The record does not disclose injury or death counts. A specific event revision timestamp is not disclosed.