Ventilator, Non-continuous (respirator)
Anesthesiology · 21 CFR 868.5905
Recent MDR events
300,898 adverse event reports on file
- REMstar Pro C-Flex+Jul 31, 2026MalfunctionRespironics, Inc.2518422-2026-040780
- DreamStation Auto CPAPJul 31, 2026MalfunctionRespironics, Inc.2518422-2026-040774
- DreamStation Auto CPAPJul 31, 2026MalfunctionRespironics, Inc.2518422-2026-040324
- DreamStation Auto CPAPJul 31, 2026MalfunctionRespironics, Inc.2518422-2026-040576
- DreamStation Auto CPAPJul 31, 2026MalfunctionRespironics, Inc.2518422-2026-040710
- DreamStation Auto CPAPJul 31, 2026MalfunctionRespironics, Inc.2518422-2026-040379
- DreamStation ExpertJul 31, 2026MalfunctionRespironics, Inc.2518422-2026-040634
- DreamStation ExpertJul 31, 2026MalfunctionRespironics, Inc.2518422-2026-040608
- DreamStation Auto CPAPJul 31, 2026MalfunctionRespironics, Inc.2518422-2026-040610
- DreamStation Auto CPAPJul 31, 2026MalfunctionRespironics, Inc.2518422-2026-040582
Event type breakdown
Recalls
81 recall events for this product code
- 3B Medical, Inc.Open, ClassifiedJul 15, 2026
Brand Name: Rio" II
Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
Z-2740-2026 · View FDA record ↗ - Philips Respironics, Inc.Open, ClassifiedAug 8, 2025
DreamStation Auto CPAP. Non-Continuous Ventilator.
Devices may possess a programming error resulting in an incorrect device configuration.
Z-2227-2025 · View FDA record ↗ - Philips Respironics, Inc.Open, ClassifiedAug 8, 2025
DreamStation Auto BiPAP. Non-Continuous Ventilator.
Devices may possess a programming error resulting in an incorrect device configuration.
Z-2228-2025 · View FDA record ↗ - Philips Respironics, Inc.Open, ClassifiedAug 8, 2025
DreamStation Auto. Non-Continuous Ventilator.
Devices may possess a programming error resulting in an incorrect device configuration.
Z-2229-2025 · View FDA record ↗ - SleepNet CorporationOpen, ClassifiedApr 1, 2024
Mojo Full Face with Headgear, All Sizes
Update to contraindications and warning language due to CPAP masks containing magnets.
Z-1351-2024 · View FDA record ↗ - SleepNet CorporationOpen, ClassifiedApr 1, 2024
Mojo Non Vented Full Face Mask with Headgear, All Sizes
Update to contraindications and warning language due to CPAP masks containing magnets.
Z-1352-2024 · View FDA record ↗ - SleepNet CorporationOpen, ClassifiedApr 1, 2024
Mojo 2 Full Face Vented Mask, All Sizes
Update to contraindications and warning language due to CPAP masks containing magnets.
Z-1353-2024 · View FDA record ↗ - SleepNet CorporationOpen, ClassifiedApr 1, 2024
Mojo 2 Full Face Non Vented Mask, All Sizes
Update to contraindications and warning language due to CPAP masks containing magnets.
Z-1354-2024 · View FDA record ↗ - SleepNet CorporationOpen, ClassifiedApr 1, 2024
Mojo 2 Full Face AAV Non Vented Mask, All Sizes
Update to contraindications and warning language due to CPAP masks containing magnets.
Z-1355-2024 · View FDA record ↗ - SleepNet CorporationOpen, ClassifiedApr 1, 2024
iQ 2 Nasal Vented Mask
Update to contraindications and warning language due to CPAP masks containing magnets.
Z-1356-2024 · View FDA record ↗
Registered firms
724 firms currently registered for this product code
Rico Elastomere Projecting Gmbh
Thalheim bei Wels Oberosterreich, AT
Respironics Inc.
MURRYSVILLE, PA, US
Resmed Malaysia Operations Sdn Bhd
Senai Johor, MY
Bmc (tianjin) Medical Co., Ltd.
Wuqing District Tianjin, CN
Ceva Logistics Limited
Daventry Northamptonshire, GB
Breas Medical, Inc.
N Billerica, MA, US
Velcromex, S.a. De C.v.
AGUA PRIETA Sonora, MX
Wellell Inc.
NEW TAIPEI CITY, TW
Bmc Medical Co., Ltd.
Fengtai District Beijing, CN
Mehow Innovative (huizhou) Ltd.
Huizhou Guangdong, CN
Cordica Medical, Inc. (formally Team Technologies, Inc.)
Haverhill, MA, US
Respironics Deutschland Gmbh & Co.kg
Herrsching Bavaria, DE
Philips Electronics Ltd
Mississauga Ontario, CA
Resmed Asia Pte. Ltd.
Singapore South West, SG
Respironics Medical Products (shenzhen) Co., Ltd.
Shenzhen Guangdong, CN
Rmo
Johor Bahru, MY
Salter Labs
El Paso, TX, US
Bleep, Llc
Chapel Hill, NC, US
Aurora Technology Pte. Ltd.
Singapore North East, SG
510(k) clearances
461 clearances for this product code
- Resvent Medical Technology Co., Ltd.Jul 23, 2026
K253044 · RXiBreeze PAP System (RXiBreeze 20C)
- Resmed CorpJun 4, 2026
K253553 · Orion
- Resmed CorpMay 27, 2026
K254104 · ResScan Essentials
- Dcstar, Inc.May 21, 2026
K251920 · Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask
- BMC Medical Co., Ltd.Apr 29, 2026
K253166 · F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)
- Somnetics International, Inc. (Dba Transcend Inc)Apr 17, 2026
K252338 · MySleepDash
- Sleepnet CorporationJan 15, 2026
K251847 · Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask
- RemSleep Holdings, Inc.Jan 7, 2026
K253939 · DeltaWave Nasal Pillow System