BMC Medical Luna G3 APAP Devices Recalled for Retroactive Rework Reporting
BMC Medical is recalling 20,160 Luna G3 APAP devices to report 2024 rework conducted at a warehouse.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse"
Plain-English summary
BMC Medical Co., Ltd. is recalling 20,160 units of the BMC/REACTHEALTH Luna G3 APAP (REF LG 3600) medical device. The recall is initiated for retroactive reporting of rework that was conducted in 2024 at the 3B/React Health warehouse.
The affected devices are identified by UDI 06948538363331 and 06948538365892, with software version G3-2.00.76. The source text does not specify the specific nature of the rework or the potential safety hazards associated with it. The distribution pattern is listed as US distribution to FL, with no other US states specified.
Consumers and healthcare providers should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected. The source text does not provide specific consumer instructions or contact information for the recall.
The recalled product
- Product
- BMC/REACTHEALTH Luna G3 APAP REF LG 3600
- Manufacturer
- BMC Medical Co., Ltd.
- Hazard
- Affected units
- 20,160
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 06948538363331
Distribution
Distributed in 1 state:
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