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FDA DevicesClass I

BMC/REACTHEALTH Luna G3 APAP REF LG 3600

Published: August 26, 2026Recall ID: Z-2979-2026Category: Medical DevicesCountry: United States
US
Medical DeviceFDA DevicesUSUS

BMC/REACTHEALTH Luna G3 APAP REF LG 3600

Recalling Firm: BMC Medical Co., Ltd.

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Reason for Recall / Hazard

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

Product Description & Identification

BMC/REACTHEALTH Luna G3 APAP REF LG 3600

Affected Products

BMC/REACTHEALTH Luna G3 APAP REF LG 3600

Additional Source Details

FieldValue
CityBeijing
Event id99445
Address 1Room 10, 17F, Building 4, Huiya Plaza, No.16 Lize Road Fengtai District
Code infoUDI: 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 A31249... [TRUNCATED]
Postal codeN/A
Report date20260826
Product typeDevices
Product quantity20,160 units
Reason for recallRetroactive reporting for 2024 rework conducted at the 3B/React Health warehouse
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260715
Initial firm notificationE-Mail
Center classification date20260819

Consumer Action Protocol: What You Should Do Immediately

Safety Steps
1Verify Product Identifiers

Inspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.

2Isolate & Discontinue Use

Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.

3Claim Free Statutory Remedy

Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.

4Report Adverse Incidents

If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).

Your Legal Rights as a Consumer

Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.

Frequently Asked Questions About This Recall

FAQ Guide

Q1:What should I do immediately if I own or bought BMC/REACTHEALTH Luna G3 APAP REF LG 3600?

Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.

Q2:Can I get a full refund or free repair for this recall?

Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.

Q3:Do I need my original sales receipt to claim a remedy or refund?

In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.

Q4:Where can I verify official information for this safety alert?

This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.

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Overview

  • Recalling FirmBMC Medical Co., Ltd.
  • StatusOngoing
  • Risk LevelClass I
  • DistributionUS distribution to: FL OUS: None
Recall Hazard Severity
High Alert (Class I)
Official Agency Alert

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🚨 SAFETY ALERT: BMC Medical Co., Ltd. - BMC/REACTHEALTH Luna G3 APAP REF LG 3600

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https://therecallfile.com/recalls/bmc-reacthealth-luna-g3-apap-ref-lg-3600/FDA-Z-2979-2026
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