Category

Respiratory Devices Recalls

629 respiratory devices recalls on record from CPSC, FDA, and USDA.

629 recalls
CriticalFDA
Smiths Medical Asd Inc.
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
Respiratory Devices·10,140 affected·Feb 7, 2024
CriticalFDA
Smiths Medical Asd Inc.
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
Respiratory Devices·2,902 affected·Feb 7, 2024
CriticalFDA
Vyaire Medical
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expiratory Filter, REF 2K8005F
Respiratory Devices·2,070 affected·Jan 10, 2024
CriticalFDA
Vyaire Medical
AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017
Respiratory Devices·1,020,330 affected·Jan 10, 2024
CriticalFDA
Vyaire Medical
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8005
Respiratory Devices·3,683,407 affected·Jan 10, 2024
CriticalFDA
Vyaire Medical
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2
Respiratory Devices·3,636 affected·Jan 10, 2024
CriticalFDA
Vyaire Medical
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F
Respiratory Devices·8,220 affected·Jan 10, 2024
CriticalFDA
Vyaire Medical
AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2
Respiratory Devices·4,572 affected·Jan 10, 2024
High RiskFDA
Olympus Corporation Of The Americas
Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044
Respiratory Devices·600 affected·Dec 11, 2023
High RiskFDA
Biofire Diagnostics, Llc
The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0 or...
Respiratory Devices·57 affected·Nov 27, 2023
CriticalFDA
Medline Industries, Lp - Northfield
MEDLINE Kits, trays, and packs labeled as follows: a) ASC GENERAL MINOR CDS, REF CDS983673G; b) ASC GENERAL MINOR CDS, REF CDS983673...
Respiratory Devices·3,297 affected·Nov 15, 2023
High RiskFDA
Vyaire Medical
vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
Respiratory Devices·16 affected·Oct 27, 2023
High RiskFDA
Breas Medical, Inc.
with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS. ...
Respiratory Devices·215 affected·Oct 13, 2023
High RiskFDA
Maquet Medical Systems Usa
Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
Respiratory Devices·1,022 affected·Oct 12, 2023
High RiskFDA
Mc3 Inc
NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxi...
Respiratory Devices·299 affected·Oct 11, 2023
CriticalFDA
Resmed Ltd.
Astral 100 and Astral 150 ventilators
Respiratory Devices·55,279 affected·Sep 13, 2023
CriticalFDA
Philips Respironics, Inc.
Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Phil...
Respiratory Devices·15 affected·Aug 25, 2023
High RiskFDA
O&m Halyard, Inc.
FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827
Respiratory Devices·41,790 affected·Aug 9, 2023
CriticalFDA
Hamilton Medical, Inc.
Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator
Respiratory Devices·6 affected·Jul 26, 2023
CriticalFDA
Hamilton Medical, Inc.
Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator
Respiratory Devices·76 affected·Jul 26, 2023
CriticalFDA
Hamilton Medical, Inc.
Hamilton-MR1, REF: 161010, Intensive Care Ventilator
Respiratory Devices·12 affected·Jul 26, 2023
CriticalFDA
Hamilton Medical, Inc.
Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator
Respiratory Devices·164 affected·Jul 26, 2023
CriticalFDA
Hamilton Medical, Inc.
Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator
Respiratory Devices·4 affected·Jul 26, 2023
CriticalFDA
Hamilton Medical, Inc.
Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator
Respiratory Devices·1,216 affected·Jul 26, 2023
CriticalFDA
Draeger Medical, Inc.
Carina Sub-Acute Care Ventilator
Respiratory Devices·11,621 affected·Jul 12, 2023
CriticalFDA
Hamilton Medical, Inc.
HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optional...
Respiratory Devices·701 affected·Jun 15, 2023
CriticalFDA
Hamilton Medical, Inc.
HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory support to adults an...
Respiratory Devices·2,319 affected·Jun 15, 2023
CriticalFDA
Hamilton Medical, Inc.
HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants a...
Respiratory Devices·399 affected·Jun 15, 2023
CriticalFDA
Draeger Medical, Inc.
Oxylog 3000 Plus emergency and transport ventilator
Respiratory Devices·300 affected·Jun 12, 2023
High RiskFDA
Qiagen Gmbh
QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients s...
Respiratory Devices·386 affected·May 19, 2023
High RiskFDA
Qiagen Gmbh
QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intended for analyzing n...
Respiratory Devices·4,155 affected·May 19, 2023
High RiskFDA
Maquet Medical Systems Usa
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 10000-USA ...
Respiratory Devices·0 affected·May 18, 2023
High RiskFDA
Maquet Medical Systems Usa
QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ-HMO 50000-USA ...
Respiratory Devices·1,784 affected·May 18, 2023
High RiskFDA
Maquet Medical Systems Usa
QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HM...
Respiratory Devices·0 affected·May 18, 2023
High RiskFDA
Maquet Medical Systems Usa
BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass Item no. 701067905
Respiratory Devices·1,784 affected·May 18, 2023
High RiskFDA
Maquet Medical Systems Usa
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 10000-USA 701070412 HMO ...
Respiratory Devices·0 affected·May 18, 2023
High RiskFDA
Maquet Medical Systems Usa
QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 70000-USA ...
Respiratory Devices·0 affected·May 18, 2023
High RiskFDA
Maquet Medical Systems Usa
QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMOD 70000-USA 701...
Respiratory Devices·24,250 affected·May 18, 2023
High RiskFDA
Maquet Medical Systems Usa
QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. BEQ-HMOD30000-U...
Respiratory Devices·5,022 affected·May 18, 2023
High RiskFDA
Maquet Medical Systems Usa
BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859
Respiratory Devices·15,880 affected·May 18, 2023
High RiskFDA
Maquet Medical Systems Usa
QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 70000-USA 701067820 HMO 7...
Respiratory Devices·0 affected·May 18, 2023
High RiskFDA
Dre Medical Group Inc
Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage ...
Respiratory Devices·22 affected·May 15, 2023
High RiskFDA
Qiagen Gmbh
QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the foll...
Respiratory Devices·368 affected·May 9, 2023
High RiskFDA
Biofire Diagnostics, Llc
BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only
Respiratory Devices·705 affected·May 8, 2023
CriticalFDA
Draeger Medical, Inc.
Set2Go Ventilation 12 (A), MP07968
Respiratory Devices·500 affected·Apr 17, 2023
High RiskFDA
Devilbiss Healthcare Llc
DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
Respiratory Devices·143,397 affected·Mar 9, 2023
High RiskFDA
Terumo Cardiovascular Systems Corporation
CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
Respiratory Devices·84 affected·Mar 1, 2023
High RiskFDA
Terumo Cardiovascular Systems Corporation
CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
Respiratory Devices·4,940 affected·Mar 1, 2023