Category

Respiratory Devices Recalls

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

629 recalls
High RiskFDA
Sentec Ag
SenTec Membrane Changer Set (1 charger plus 1 insert) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dio...
Respiratory Devices·3 affected·May 2, 2019
CriticalFDA
Pf Consumer Healthcare 1 Llc
ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, UPC 305733010037 - Product Usage: ThermaCare(R) HeatWraps are indicated in adults to pr...
Respiratory Devices·155,904 affected·Apr 26, 2019
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic gas blender prov...
Respiratory Devices·1,258 affected·Apr 18, 2019
CriticalFDA
Hamilton Medical Ag
HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are designed for intensive care ventilat...
Respiratory Devices·4,338 affected·Mar 25, 2019
CriticalFDA
O-two Medical Technologies, Inc.
e700 Automatic Transport Ventilator, Model Number 01EVE700
Respiratory Devices·632 affected·Feb 12, 2019
CriticalFDA
Draeger Medical, Inc.
ID Circuit Basic 180, Catalog Number MP01350 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conductio...
Respiratory Devices·25 affected·Dec 21, 2018
CriticalFDA
Draeger Medical, Inc.
VentStar Watertrap (P) 180, Catalog Number MP00361 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for con...
Respiratory Devices·25 affected·Dec 21, 2018
CriticalFDA
Draeger Medical, Inc.
VentStar Basic 250, Catalog Number MP00350 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction o...
Respiratory Devices·170 affected·Dec 21, 2018
CriticalFDA
Draeger Medical, Inc.
ID Circuit Watertrap (P) 180, Catalog Number MP01341 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for ...
Respiratory Devices·25 affected·Dec 21, 2018
CriticalFDA
Draeger Medical, Inc.
VentStar Basic (P) 250, Catalog Number MP00352 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduct...
Respiratory Devices·75 affected·Dec 21, 2018
CriticalFDA
Draeger Medical, Inc.
VentStar Basic 180, Catalog Number MP00349 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction ...
Respiratory Devices·325 affected·Dec 21, 2018
CriticalFDA
Draeger Medical, Inc.
VentStar Basic (P) 180, Catalog Number MP00351 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduct...
Respiratory Devices·525 affected·Dec 21, 2018
CriticalFDA
Draeger Medical, Inc.
ID Circuit Basic 250, Catalog Number MP01348 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conductio...
Respiratory Devices·20 affected·Dec 21, 2018
High RiskFDA
Cincinnati Sub-zero Products Llc, A Gentherm Company
Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM¿ Model 400CE Dual Reservoir Cooler/Heater is ...
Respiratory Devices·396 affected·Dec 19, 2018
CriticalFDA
Ge Healthcare, Llc
GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b) 2083208-001 (box of ten singles) ...
Respiratory Devices·1,140 affected·Oct 5, 2018
High RiskFDA
Ohmeda Medical
Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as ...
Respiratory Devices·0 affected·Oct 5, 2018
High RiskFDA
Ge Healthcare, Llc
Aisys CS2 Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UP...
Respiratory Devices·4,207 affected·Sep 27, 2018
High RiskFDA
Ge Healthcare, Llc
Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 11.X ENGLISH FOR USA, TOUCHSCREEN DISPLAY KIT ...
Respiratory Devices·4,207 affected·Sep 27, 2018
CriticalFDA
Covidien Llc
Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric Adult Ventilator Puritan Bennett" 980 Neonatal Ventilat...
Respiratory Devices·9,593 affected·Sep 18, 2018
High RiskFDA
Sanrai International Llc
Sunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compressor Nebulizer is an AC-powered air nebulizer compressor syst...
Respiratory Devices·150 affected·Aug 29, 2018
High RiskFDA
Ohio Medical Corporation
Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style 758000, Model CARE-E-VAC 3, Ohio Medical LLC ...
Respiratory Devices·1,443 affected·Aug 14, 2018
High RiskFDA
A M Systems Inc
Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer. This tubing is supplied non-sterile P/N: 1024920 Rev. 01 L...
Respiratory Devices·610 affected·Aug 10, 2018
High RiskFDA
Pom Medical Llc
POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med ...
Respiratory Devices·5,610 affected·Jul 11, 2018
CriticalFDA
Spacelabs Healthcare, Ltd.
Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This...
Respiratory Devices·328 affected·Jul 11, 2018
RecallFDA
Smiths Medical Asd Inc.
smiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. P...
Respiratory Devices·3,000 affected·Jul 6, 2018
RecallFDA
Smiths Medical Asd Inc.
smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Prod...
Respiratory Devices·12,000 affected·Jul 6, 2018
RecallFDA
Smiths Medical Asd Inc.
smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas Monitoring Line, 305 cm (10ft.) & Female Luer Connector, 21...
Respiratory Devices·850 affected·Jul 6, 2018
RecallFDA
Smiths Medical Asd Inc.
smiths medical portex First Breath Adult Nasal Cannula, REF 001285, Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product ...
Respiratory Devices·2,550 affected·Jul 6, 2018
High RiskFDA
Terumo Cardiovascular Systems Corporation
CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product Usage: The CDI System 500 provides continuous, on-line monit...
Respiratory Devices·128 affected·Jun 26, 2018
High RiskFDA
Terumo Cardiovascular Systems Corporation
Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT Monitor with two Blood Parameter modules and one HSat Probe; 500AVHC...
Respiratory Devices·128 affected·Jun 26, 2018
CriticalFDA
Compass Health Brands (corporate Office)
CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L Product Usage: A CPAP mask is attached to an end user s fac...
Respiratory Devices·742 affected·Jun 18, 2018
High RiskFDA
Sun Med, Llc
MEDLINE ADULT MANUAL RESUSCITATOR WITH LARGE ADULT MASK, TUBE RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1126FL
Respiratory Devices·60 affected·May 24, 2018
High RiskFDA
Sun Med, Llc
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1126FP
Respiratory Devices·361 affected·May 24, 2018
High RiskFDA
Sun Med, Llc
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1116P
Respiratory Devices·80 affected·May 24, 2018
High RiskFDA
Sun Med, Llc
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1126F
Respiratory Devices·110 affected·May 24, 2018
High RiskFDA
Sun Med, Llc
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1116
Respiratory Devices·1,742 affected·May 24, 2018
High RiskFDA
Sun Med, Llc
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, PEEP VALVE, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1116PC
Respiratory Devices·40 affected·May 24, 2018
High RiskFDA
Sun Med, Llc
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1116F
Respiratory Devices·60 affected·May 24, 2018
High RiskFDA
Sun Med, Llc
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1126
Respiratory Devices·350 affected·May 24, 2018
CriticalFDA
Draeger Medical, Inc.
Perseus A500 Anesthesia Machine; Cat. no. MK06000 Product V Product Usage: Intended for use in anesthetizing adults, children, and...
Respiratory Devices·33 affected·May 24, 2018
CriticalFDA
Draeger Medical, Inc.
Fabius GS Tiro Anesthesia Machine; Cat. no. 8606000 Product Usage: Inhalation anesthesia machines for use in operating, induction and...
Respiratory Devices·31 affected·May 24, 2018
High RiskFDA
Sun Med, Llc
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK 5, BAG RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1116PD5
Respiratory Devices·55 affected·May 24, 2018
CriticalFDA
Draeger Medical, Inc.
Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 Product Usage: Inhalation anesthesia machines for use in operating, induction ...
Respiratory Devices·62 affected·May 24, 2018
CriticalFDA
Draeger Medical, Inc.
Fabius GS MRI Anesthesia Machine; Cat. no. 8607300 Product Usage: Inhalation anesthesia machines for use in operating, induction and ...
Respiratory Devices·4 affected·May 24, 2018
High RiskFDA
Dynarex Corporation
Dynarex CGA870 All Brass Oxygen Regulator, All Brass - 0-25 LPM, Barb & 2-DISS Outlet, UPC: 616784522715, Model Number 5227 A pressur...
Respiratory Devices·15 affected·May 8, 2018
CriticalFDA
Vyaire Medical
AirLife Resuscitation Device, Adult labeled as the following: a. Adult, with mask, oxygen reservoir bag, Part Number 2K8004; b....
Respiratory Devices·15,714 affected·May 8, 2018
CriticalFDA
Vyaire Medical
AirLife Resuscitation Device, Pediatric labeled as the following: a. Pediatric, with mask, 28" large bore tubing, pressure-relief va...
Respiratory Devices·15,714 affected·May 8, 2018
High RiskFDA
Teleflex Medical Europe Ltd
Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 (b) 153000005 153000005 (c) 153000010 153000010 (d) 153000...
Respiratory Devices·107,962 affected·Mar 15, 2018