BMC/REACTHEALTH Luna G3 APAP Recall Issued by FDA
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FDA announces ongoing Class I recall of 20,160 BMC/REACTHEALTH Luna G3 APAP REF LG 3600 devices distributed to Florida.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on September 9, 2026 and geographically references Florida, United States. The FDA classifies this as a Class I recall, with the stated reason "Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse", distributed us distribution to: fl ous: none. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
The FDA has classified a recall of the BMC/REACTHEALTH Luna G3 APAP REF LG 3600 as Class I. The recalling firm, BMC Medical Co., Ltd., initiated the action for retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse.
Which Products Are Affected
The recall covers 20,160 units of BMC/REACTHEALTH Luna G3 APAP REF LG 3600 (UDI: 06948538363331; 06948538365892; Software Version: G3-2.00.76). Distribution was limited to Florida in the US.
What You Should Do
No specific consumer action steps are provided in the recall notice.
Why This Matters
This is an ongoing Class I recall involving over 20,000 units of a medical device.
Source
FDA recall number Z-2979-2026. Attribution: FDA.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (737 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to September 9, 2026.
Frequently Asked Questions
Common questions about this FDA recall.