BMC/REACTHEALTH Luna G3 APAP
Medical device recall Z-2979-2026. Published in FDA’s Enforcement Report on Aug 26, 2026.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Aug 26, 2026. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- Florida the one state its words name
- 20,160 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
BMC/REACTHEALTH Luna G3 APAP REF LG 3600
20,160 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI: 06948538363331; 06948538365892 Software Version: G3-2.00.76 Serial Numbers: A3124919140 A3124919145 A3124919181 A3124918105 A3124919105 A3124919148 A3124919131 A3124919151 A3124919130 A3124919147 A3124919153 A3124919126 A3124919149…
Every code shown here, 1,989 characters
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 A3124918528 A3124918294 A3124918362 A3124918529 A3124918358 A3124918374 A3124918516 A3124918364 A3124918509 A3124918511 A3124918366 A3124918385 A3124918372 A3124918376 A3124918263 A3124918512 A3124918380 A3124918287 A3124918085 A3124918300 A3124918297 A3124917180 A3124919172 A3124919058 A3124919054 A3124919116 A3124919057 A3124919189 A3124919112 A3124919115 A3124918327 A3124919100 A3124918197 A3124919120 A3124919191 A3124919186 A3124919118 A3124918115 A3124918317 A3124918429 A3124919137 A3124918153 A3124918207 A3124918069 A3124918323 A3124918023 A3124918136 A3124918070 A3124918081 A3124918134 A3124918051 A3124918114 A3124918283 A3124917222 A3124918182 A3124918030 A3124917146 A3124918037 A3124918180 A3124918185 A3124918169 A3124918042 A3124918183 A3124918056 A3124918166 A3124918038 A3124918163 A3124918448 A3124917327 A3124918160 A3124918444 A3124918124 A3124918441 A3124918107 A3124918256 A3124918119 A3124918128 A3124918450 A3124918447 A3124918123 A3124918112 A3124918431 A3124918293 A3124918440 A3124918428 A3124919087 A3124919008 A3124917075 A3124917345 A3124917393 A3124917129 A3124917305 A3124917059 A3124917277 A3124917070 A3124917103 A3124917061 A3124917308 A3124917385 A3124917376 A3124917392 A3124917156 A3124917133 A3124919185 A3124917055 A3124918032 A3124917144 A3124917391 A3124917151 A3124918168 A3124918325 A3124918164 A3124918120 A3124918439 A3124918044 A3124918449…
FDA’s list runs to 242,007 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US distribution to: FL OUS: None
The states and territories these words name
- Florida
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jul 15, 2026.
- FDA classified it on Aug 19, 2026.
- FDA’s Enforcement Report published it on Aug 26, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- BMC Medical Co., Ltd., of Beijing, China.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 242,007 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.