Nebulizer (direct Patient Interface)
Anesthesiology · 21 CFR 868.5630
Recent MDR events
2,847 adverse event reports on file
- HUDSON RCIJul 31, 2026MalfunctionMedline Industries, Lp1417592-2026-08048
- Hudson RCIJul 30, 2026MalfunctionMedline Industries, Lp1417592-2026-08091
- NEBULIZER PARI PLUS LCJul 30, 2026OtherMW6000156
- MedlineJul 28, 2026MalfunctionMedline Industries, Lp1417592-2026-07988
- InnoSpire EssenceJul 27, 2026MalfunctionRespironics, Inc.2518422-2026-039694
- MEDLINEJul 22, 2026MalfunctionMedline Industries, Lp1417592-2026-07557
- NEBULIZER AIR FILTERJul 21, 2026MalfunctionPari Respiratory Equipment, Inc.MW5190935
- VIOS LC AEROSOL DELIV SYSTJul 21, 2026InjuryPari Respiratory Equipment, Inc.MW5190945
- LC PLUSJul 21, 2026OtherMW6000116
- NEBULIZER PARI PLUS LCJul 21, 2026OtherMW6000125
Event type breakdown
Recalls
36 recall events for this product code
- MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedSep 14, 2023
HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.
Z-2514-2023 · View FDA record ↗ - Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical CompanyTerminatedFeb 4, 2019
Portex 350 ml Sterile Water Humidifier w/5psi Adapt.
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Z-0710-2019 · View FDA record ↗ - Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical CompanyTerminatedFeb 4, 2019
Portex 550 ml Sterile Water Humidifier w/5psi Adapt.
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Z-0711-2019 · View FDA record ↗ - Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical CompanyTerminatedFeb 4, 2019
Portex 1000 ml Sterile Water USP Pour Bottle
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Z-0712-2019 · View FDA record ↗ - Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical CompanyTerminatedFeb 4, 2019
Portex 500 ml Sterile Water USP Pour Bottle
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Z-0713-2019 · View FDA record ↗ - Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical CompanyTerminatedFeb 4, 2019
Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Z-0714-2019 · View FDA record ↗ - Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical CompanyTerminatedFeb 4, 2019
Portex 550 ml Sterile Water Humidifier w/5psi Adapt.
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Z-0715-2019 · View FDA record ↗ - Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical CompanyTerminatedFeb 4, 2019
Intermed 550 ml Sterile Water Humidifier w/5psi Adapt.
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Z-0716-2019 · View FDA record ↗ - Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical CompanyTerminatedFeb 4, 2019
Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Z-0717-2019 · View FDA record ↗ - Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical CompanyTerminatedFeb 4, 2019
Medline Prefilled 350 ml Sterile
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Z-0718-2019 · View FDA record ↗
Registered firms
535 firms currently registered for this product code
Ceva Logistics Limited
Daventry Northamptonshire, GB
Globalcare Medical Technology Hk, Ltd.
Hong Kong, HK
Asia Connection Co., Ltd.
New Taipei City, TW
Icu Medical, Inc.
DUBLIN, OH, US
Allied Medical Llc
Earth City, MO, US
Sunmed Group Holdings, Llc
Grand Rapids, MI, US
Pari Respiratory Equipment, Inc.
MIDLOTHIAN, VA, US
Joytech Healthcare Co.,ltd.
Hangzhou Zhejiang, CN
Intersurgical Ltd.
WOKINGHAM, BERKSHIRE, GB
Tecnologias Medicas Innovadoras S De Rl
H. MATAMOROS Tamaulipas, MX
Philips Electronics Ltd
Mississauga Ontario, CA
Plaxtron Industrial (m) Sdn. Bhd.
IPOH Perak, MY
Bi-rich Medical Devices (cambodia) Co. Ltd
BAVET Svay Rieng, KH
Trudell Medical International
LONDON Ontario, CA
Aerogen Ltd
DANGAN Galway, IE
Ceva Logistics Netherlands Bv (venray)
Oostrum Limburgh, NL
Hsiner Co., Ltd.
TAICHUNG CITY, TW
Westmed Javid De Mexico, S.a. De C.v.
NOGALES Sonora, MX
Simple Diagnostics
Maspeth, NY, US
Medi Nuclear Corp., Inc.
BALDWIN PARK, CA, US
510(k) clearances
508 clearances for this product code
- FindAir Sp. z o.o.Jun 2, 2026
K260270 · FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)
- Pari Respiratory Equipment, Inc.Dec 19, 2025
K251572 · eRapid with eTrack System
- Qingdao Future Medical Technology Co., Ltd.Nov 14, 2025
K251659 · Mesh Nebulizer (H6)
- Shenzhen Jermei Medical Device Technology Co., Ltd.Sep 19, 2025
K244035 · Portable mesh nebulizer (JM821)
- Joytech Healthcare Co. , Ltd.Jul 2, 2025
K243468 · Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)
- VoluntisJun 30, 2025
K250022 · HeroTracker Sense
- Hcmed Innovations Co., Ltd.Jun 20, 2025
K250583 · AdheResp Smart Breath-actuated Mesh Nebulizer
- Enchant Tek Co. , Ltd.Apr 29, 2025
K242354 · AllNEB