OVERLOOKED

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Class IOngoing

BMC Medical Co., Ltd. recalls BMC/REACTHEALTH Luna G3 APAP REF LG 3600

Recall date · record updated Aug 26, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
BMC Medical Co., Ltd.
Reason
Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse
Hazard
FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).
Who’s affected
US distribution to: FL OUS: None
Where
Florida
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99445…

Products

  1. BMC/REACTHEALTH Luna G3 APAP REF LG 3600

    Codes/lots: UDI: 06948538363331; 06948538365892 Software Version: G3-2.00.76 Serial Numbers: A3124919140 A3124919145 A3124919181 A3124918105 A3124919105 A3124919148 A3124919131 A3124919151 A3124919130 A3124919147 A3124919153 A3124919126 A3124919149 A3124919144 A3124918225 A3124918400 A3124918379 A3124918407 A3124918228 A3124918390 A3124918398 A3124918268 A3124918260 A3124918341 A3124918259 A3124918285 A3124918251 A3124918464 A3124918255 A3124918257 A3124918261 A3124918172 A3124918267 A3124918266 A3124918280 A3124918212 A3124918269 A3124918382 A3124918271 A3124918130 A3124918246 A3124918525 A3124918282 A31Quantity: 20,160 unitsRecall no. Z-2979-2026Class I

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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