Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
High RiskFDA
Fresenius Medical Care Holdings, Inc.
RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Medical Devices·17 affected·Jun 3, 2024
High RiskFDA
Microtek Medical Inc.
Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
Medical Devices·135,999 affected·Jun 3, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Medical Devices·6 affected·Jun 3, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Medical Devices·372 affected·Jun 3, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Medical Devices·1,156 affected·Jun 3, 2024
High RiskFDA
Stryker Corporation
The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with commercially available gowns. The hood ...
Medical Devices·4 affected·Jun 3, 2024
High RiskFDA
Nalu Medical, Inc.
Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), REF: 71019-US C...
Medical Devices·13 affected·Jun 3, 2024
High RiskFDA
Microtek Medical Inc.
Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
Medical Devices·30,435 affected·Jun 3, 2024
High RiskFDA
Aspen Surgical
Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101
Medical Devices·1,900 affected·Jun 3, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Medical Devices·531 affected·Jun 3, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Medical Devices·2 affected·Jun 3, 2024
High RiskFDA
Radiometer Medical Aps
ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole bl...
Medical Devices·27,127 affected·May 31, 2024
High RiskFDA
Stryker Sustainability Solutions
REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly
Medical Devices·90 affected·May 31, 2024
High RiskFDA
Maquet Cardiovascular, Llc
The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Length Endoscope. Th...
Medical Devices·600 affected·May 31, 2024
High RiskFDA
Avanos Medical, Inc.
MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT); and MIC-KEY* ...
Medical Devices·53,384 affected·May 31, 2024
CriticalFDA
Siemens Medical Solutions Usa, Inc
AXIOM Vertix MD - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in o...
Medical Devices·2 affected·May 31, 2024
CriticalFDA
Siemens Medical Solutions Usa, Inc
MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix P...
Medical Devices·3 affected·May 31, 2024
High RiskFDA
Olympus Corporation Of The Americas
Soltive Premium SuperPulsed Laser System, Model TFL-PLS
Medical Devices·1,585 affected·May 31, 2024
CriticalFDA
Baxter Healthcare Corporation
Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positi...
Medical Devices·58,220 affected·May 30, 2024
High RiskFDA
Dental Ez Group Star Dental Division
Titan Scaler Tip - Perio Model/Catalog Number: 261669 The scaler tip is used with an air drive scaler for subgingival scaling and fi...
Medical Devices·32 affected·May 30, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Numb...
Medical Devices·0 affected·May 29, 2024
High RiskFDA
Getinge Usa Sales Inc
ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B4
Medical Devices·73 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOM...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM PEDIATRIC UNCUFFED FLEXTEND PLUS TRACHEOSTOMY TUBE WITH NEONATE STRAIGHT N...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code ...
Medical Devices·0 affected·May 29, 2024
High RiskFDA
Getinge Usa Sales Inc
ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322F5
Medical Devices·7 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/List Number/Item C...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number...
Medical Devices·0 affected·May 29, 2024
High RiskFDA
Getinge Usa Sales Inc
ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B5
Medical Devices·171 affected·May 29, 2024
High RiskFDA
Cardinal Health 200, Llc
Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA; 2) Neurological Tray, Catalog Number SAN29NRCC1...
Medical Devices·13,487 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Nu...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N030; b) NEONAT...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Product Code/List Nu...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N025; b) ...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item C...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Co...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60N025
Medical Devices·3,138 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 6...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750...
Medical Devices·25,283 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code ...
Medical Devices·36,219 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N025; b) ...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Numb...
Medical Devices·0 affected·May 29, 2024
CriticalFDA
Smiths Medical Asd Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY TUBE 4.0MMTIGHT TO SHAFT CUFF , Product Code/List Number/Ite...
Medical Devices·0 affected·May 29, 2024
High RiskFDA
Hitachi America, Ltd., Particle Therapy Division
Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-FR is a...
Medical Devices·1 affected·May 27, 2024
High RiskFDA
Hitachi America, Ltd., Particle Therapy Division
Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-V is a p...
Medical Devices·1 affected·May 27, 2024
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
Medical Devices·13,565 affected·May 27, 2024
High RiskFDA
Cue Health Inc
Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
Medical Devices·56 affected·May 24, 2024