Home › Device types › NHJ
Device, Positive Pressure Breathing, Intermittent
FDA product code NHJ · Class 2 · Anesthesiology
220
Registered devices
189
Adverse events
10
Recalls
25
510(k) clearances
Devices with this code
Maximus System — HILL-ROM SERVICES PTE. LTD.VOCSN Patient Breathing Package — Ventec Life Systems, Inc.Percussionaire — PERCUSSIONAIRE CORPORATIONPercussionaire — PERCUSSIONAIRE CORPORATIONVORTRAN PercussiveNEB 2.0 w/ Top Nebulizer Port — VORTRAN MEDICAL TECHNOLOGY 1, INCVolara System — HILL-ROM SERVICES PTE. LTD.The MetaNeb®System — HILL-ROM SERVICES PTE. LTD.Percussionaire — PERCUSSIONAIRE CORPORATIONVOCSN Patient Breathing Package — Ventec Life Systems, Inc.Synclara Cough System — HILL-ROM SERVICES PTE. LTD.VOCSN Patient Breathing Package — Ventec Life Systems, Inc.CoughAssist — Respironics, Inc.BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Medium — Abmrc LLCThe VitalCough®System — HILL-ROM SERVICES PTE. LTD.VOCSN — Ventec Life Systems, Inc.ATOS — Respironics, Inc.CoughAssist — Respironics, Inc.Percussionaire — PERCUSSIONAIRE CORPORATIONCoughAssist — Respironics, Inc.Percussionaire — PERCUSSIONAIRE CORPORATIONVOCSN Power Supply — Ventec Life Systems, Inc.CoughAssist — Respironics, Inc.CoughAssist — Respironics, Inc.Synclara Cough System — HILL-ROM SERVICES PTE. LTD.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-21 | Baxter Healthcare Corporation | There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxyge |
| 2026-05-21 | Baxter Healthcare Corporation | There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxyge |
| 2026-05-21 | Baxter Healthcare Corporation | There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxyge |
| 2026-05-21 | Baxter Healthcare Corporation | There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxyge |
| 2026-02-18 | Baxter Healthcare Corporation | Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible |
| 2024-09-16 | Percussionaire Corporation | As a result of product complaints, breathing circuits are experiencing discolored fluid which are formed when therapy was being given with specific medication t |
| 2024-05-30 | Baxter Healthcare Corporation | Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and |
| 2024-05-30 | Baxter Healthcare Corporation | Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and |
| 2022-04-26 | Baxter Healthcare Corporation | There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment. |
| 2022-04-26 | Baxter Healthcare Corporation | There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment. |
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