Class I U.S. Food and Drug Administration

BMC/Reacthealth Luna G3 Apap REF LG 3600 recall: Retroactive reporting for 2024 rework conducted at the 3B/React Health

Recall published 2 months ago

Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2979-2026
Published
August 26, 2026
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
BMC Medical Co., Ltd.
Product type
Medical devices
Units affected
20,160 units
Distribution
Florida
Made in
China
Lot / code info
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 A3124918031 A3124918446 A3124918161 A3124918125 A3124918158 A3124918109 A3124918433 A3124918435 A3124918443 A3124918116 A3124918286 A3124918281 A3124918302 A3124918388 A3124918111 A3124918434 A3124918118 A3124919063 A3124919104 A3124919070 A3124919069 A3124919064 A3124919175 A3124919174 A3124919159 A3124919061 A3124919044 A3124919075 A3124919095 A3124919080 A3124919073 A3124919088 A3124919055 A3124919125 A3124919187 A3124919124 A3124917150 A3124919081 A3124919188 A3124919089 A3124919121 A3124919195 A3124917074 A3124917314 A3124917262 A3124917066 A3124917072 A3124917145 A3124917387 A3124917058 A3124917123 A3124917403 A3124917400 A3124917263 A3124917386 A3124917397 A3124917261 A3124917054 A3124917382 A3124917264 A3124917244 A3124917187 A3124919060 A3124919035 A3124919076 A3124919119 A3124920166 A3124920156 A3124920159 A3124920142 A3124920148 A3124920205 A3124920130 A3124918202 A3124920114 A3124920123 A3124920189 A3124920194 A3124918363 A3124920167 A3124918159 A3124918034 A3124918233 A3124920136 A3124920129 A3124918104 A3124920145 A3124920171 A3124920122 A3124920149 A3124918432 A3124920188 A3124920198 A3124920204 A3124920195 A3124920192 A3124920185 A3124918348 A3124920200 A3124918299 A3124920143 A3124920160 A3124918291 A3124918292 A3124920147 A3124918526 A3124920138 A3124918151 A3124918521 A3124918284 A3124918520 A3124918370 A3124918320 A3124918354 A3124918359 A3124918391 A3124919052 A3124918373 A3124918510 A3124918507 A3124918500 A3124918356 A3124918515 A3124918508 A3124918008 A3124918082 A3124918084 A3124918018 A3124918079 A3124918188 A3124918016 A3124918073 A3124918003 A3124918065 A3124918022 A3124918074 A3124918145 A3124918187 A3124918194 A3124918201 A3124918067 A3124918004 A3124918013 A3124918192 A3124918210 A3124918205 A3124918059 A3124918036 A3124918058 A3124918126 A3124918174 A3124918057 A3124918165 A3124918451 A3124918157 A3124918442 A3124918156 A3124918430 A3124918108 A3124918110 A3124918296 A3124918106 A3124918288 A3124918438 A3124918127 A3124918171 A3124917057 A31249…
UPC codes
06948538363331, 06948538365892

Products covered by this recall

BMC/REACTHEALTH Luna G3 APAP REF LG 3600

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 06948538363331
  • 06948538365892

Model or item number

On the rating label, the box or the instruction sheet.

  • LG 3600 — UDI

Serial number

On the rating plate, often next to the date of manufacture.

  • A3124919140 A3124919145 A3124919181 A3124

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

BMC Medical Co., Ltd. — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: BMC Medical Co., Ltd. — Room 10, 17F, Building 4, Huiya Plaza, No.16 Lize Road Fengtai District, Beijing

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was BMC Medical Co., Ltd. medical devices recalled?

Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 06948538363331, 06948538365892; model number LG 3600 — UDI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Which states were affected?

The notice lists Florida.

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