Category

Medical Devices Recalls

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

15,654 recalls
CriticalFDA
Baxter Healthcare Corporation
The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
Medical Devices·19,861 affected·Jun 15, 2023
High RiskFDA
Megadyne Medical Products, Inc.
MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suct...
Medical Devices·241,457 affected·Jun 15, 2023
High RiskFDA
Philips North America Llc
IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: ...
Medical Devices·153 affected·Jun 14, 2023
CriticalFDA
Abiomed, Inc.
Impella LD intravascular micro axial blood pump, Product Number 005082
Medical Devices·9,252 affected·Jun 14, 2023
CriticalFDA
Abiomed, Inc.
Impella 5.0 intravascular micro axial blood pump, Product Number 005062
Medical Devices·9,252 affected·Jun 14, 2023
CriticalFDA
Abiomed, Inc.
Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080
Medical Devices·9,252 affected·Jun 14, 2023
High RiskFDA
Diasorin Molecular Llc
Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Di...
Medical Devices·47,878 affected·Jun 14, 2023
High RiskFDA
Wright Medical Technology, Inc.
Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
Medical Devices·106 affected·Jun 13, 2023
High RiskFDA
Philips Medical Systems Nederland B.v.
Azurion 7 M20. X-ray Image guided Therapy System.
Medical Devices·648 affected·Jun 12, 2023
High RiskFDA
Philips North America
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
Medical Devices·601 affected·Jun 12, 2023
High RiskFDA
Tornier, Inc
AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118
Medical Devices·55 affected·Jun 12, 2023
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
Medical Devices·46,033 affected·Jun 12, 2023
High RiskFDA
Philips North America
MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
Medical Devices·601 affected·Jun 12, 2023
High RiskFDA
Philips North America
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
Medical Devices·640 affected·Jun 12, 2023
High RiskFDA
Tornier, Inc
AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101
Medical Devices·55 affected·Jun 12, 2023
High RiskFDA
Philips Medical Systems Nederland B.v.
Allura Xper FD10 and FD20. X-ray Imaging System.
Medical Devices·648 affected·Jun 12, 2023
High RiskFDA
Philips North America
MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
Medical Devices·640 affected·Jun 12, 2023
CriticalFDA
Olympus Corporation Of The Americas
Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2
Medical Devices·4 affected·Jun 8, 2023
CriticalFDA
Olympus Corporation Of The Americas
Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190
Medical Devices·9,684 affected·Jun 8, 2023
High RiskFDA
Olympus Corporation Of The Americas
HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological ...
Medical Devices·62,704 affected·Jun 8, 2023
CriticalFDA
Olympus Corporation Of The Americas
Olympus BRONCHOVIDEOSCOPE, Model Numbers BF-Q170
Medical Devices·1 affected·Jun 8, 2023
CriticalFDA
Olympus Corporation Of The Americas
Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160
Medical Devices·284 affected·Jun 8, 2023
High RiskFDA
Becton Dickinson & Co.
BD Synapsys Informatics Solution, Catalog Number 444150
Medical Devices·102 affected·Jun 8, 2023
CriticalFDA
Olympus Corporation Of The Americas
Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60
Medical Devices·1,535 affected·Jun 8, 2023
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOn...
Medical Devices·3 affected·Jun 8, 2023
High RiskFDA
Microvention Inc.
FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED3524, FRED3524-CA, F...
Medical Devices·474 affected·Jun 7, 2023
High RiskFDA
Ptw-freiburg
BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is performed using Array...
Medical Devices·42 affected·Jun 7, 2023
CriticalFDA
Datex--ohmeda, Inc.
GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 2082844-002-01044956; ...
Medical Devices·224 affected·Jun 6, 2023
High RiskFDA
Neurologica Corporation
OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and ne...
Medical Devices·48 affected·Jun 6, 2023
High RiskFDA
Murata Vios, Inc.
Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
Medical Devices·44 affected·Jun 6, 2023
High RiskFDA
B. Braun Medical, Inc.
Design Options¿ / Epidural anesthesia kit (10 count carton)
Medical Devices·3,560 affected·Jun 5, 2023
CriticalFDA
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0...
Medical Devices·9,174 affected·Jun 5, 2023
CriticalFDA
Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
Medical Devices·9,174 affected·Jun 5, 2023
High RiskFDA
Exactech, Inc.
Exactech Ergo Impactor Handle, Catalog #321-09-05.
Medical Devices·784 affected·Jun 5, 2023
High RiskFDA
Siemens Medical Solutions Usa, Inc
Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Ped...
Medical Devices·9 affected·Jun 5, 2023
CriticalFDA
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0...
Medical Devices·9,174 affected·Jun 5, 2023
High RiskFDA
Luminex Corporation
VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
Medical Devices·114 affected·Jun 5, 2023
CriticalFDA
Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
Medical Devices·9,174 affected·Jun 5, 2023
High RiskFDA
Covidien, Llc
Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM
Medical Devices·6,902 affected·Jun 2, 2023
High RiskFDA
Beckman Coulter Biomedical Gmbh
Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
Medical Devices·15 affected·Jun 2, 2023
High RiskFDA
Siemens Healthcare Diagnostics Inc
epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Medical Devices·473 affected·Jun 1, 2023
CriticalFDA
Megadyne Medical Products, Inc.
MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery
Medical Devices·21,100 affected·Jun 1, 2023
CriticalFDA
Megadyne Medical Products, Inc.
MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgery
Medical Devices·21,100 affected·Jun 1, 2023
CriticalFDA
Megadyne Medical Products, Inc.
MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosurgery
Medical Devices·21,100 affected·Jun 1, 2023
CriticalFDA
Megadyne Medical Products, Inc.
MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery
Medical Devices·21,100 affected·Jun 1, 2023
CriticalFDA
Megadyne Medical Products, Inc.
MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosurgery
Medical Devices·21,100 affected·Jun 1, 2023
High RiskFDA
Micro-x Ltd.
MICRO-X Rover Mobile X-ray System, # MXU-RV35
Medical Devices·5 affected·May 31, 2023
High RiskFDA
Osteomed, Llc
REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
Medical Devices·0 affected·May 31, 2023