Category
Medical Devices Recalls
15,654 medical devices recalls on record from CPSC, FDA, and USDA.
15,654 recalls
High RiskFDA
Change Healthcare Canada Company
Horizon Cardiology Hemo. Version 12.2.
Medical Devices3 affectedAug 21, 2024
CriticalFDA
Baxter Healthcare Corporation
Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
Medical Devices2,140,046 affectedAug 20, 2024
CriticalFDA
Baxter Healthcare Corporation
Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device
Medical Devices1,548,782 affectedAug 20, 2024
CriticalFDA
Baxter Healthcare Corporation
Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
Medical Devices5,828,540 affectedAug 20, 2024
High RiskFDA
Merit Medical Systems, Inc.
basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C
Medical Devices16,439 affectedAug 19, 2024
High RiskFDA
Merit Medical Systems, Inc.
Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K0...
Medical Devices7,099 affectedAug 19, 2024
High RiskFDA
Merit Medical Systems, Inc.
basixSKY Inflation Device, REF: SKY1802
Medical Devices70 affectedAug 19, 2024
High RiskFDA
Merit Medical Systems, Inc.
MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B
Medical Devices12,910 affectedAug 19, 2024
High RiskFDA
Merit Medical Systems, Inc.
DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A
Medical Devices290 affectedAug 19, 2024
High RiskFDA
Merit Medical Systems, Inc.
Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C
Medical Devices14,120 affectedAug 19, 2024
High RiskFDA
Windstone Medical Packaging, Inc.
Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manne...
Medical Devices60 affectedAug 16, 2024
High RiskFDA
Windstone Medical Packaging, Inc.
Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient man...
Medical Devices40 affectedAug 16, 2024
High RiskFDA
Windstone Medical Packaging, Inc.
Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient mann...
Medical Devices642 affectedAug 16, 2024
High RiskFDA
Windstone Medical Packaging, Inc.
Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient mann...
Medical Devices180 affectedAug 16, 2024
High RiskFDA
Windstone Medical Packaging, Inc.
Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient m...
Medical Devices894 affectedAug 16, 2024
High RiskFDA
Carefusion 303, Inc.
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
Medical Devices180 affectedAug 15, 2024
High RiskFDA
B Braun Medical Inc
SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model...
Medical Devices10,658,351 affectedAug 15, 2024
High RiskFDA
Carefusion 303, Inc.
Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
Medical Devices192,964 affectedAug 15, 2024
High RiskFDA
B Braun Medical Inc
STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/...
Medical Devices4,984,920 affectedAug 15, 2024
High RiskFDA
B Braun Medical Inc
STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/...
Medical Devices4,671,540 affectedAug 15, 2024
High RiskFDA
B Braun Medical Inc
STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Mo...
Medical Devices9,864,165 affectedAug 15, 2024
High RiskFDA
B Braun Medical Inc
STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: ...
Medical Devices142,336 affectedAug 15, 2024
High RiskFDA
Carefusion 303, Inc.
Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
Medical Devices10,460 affectedAug 15, 2024
High RiskFDA
Carefusion 303, Inc.
Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system
Medical Devices125,017 affectedAug 15, 2024
High RiskFDA
Innovasis, Inc
TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion device inten...
Medical Devices568 affectedAug 14, 2024
High RiskFDA
3m Company - Health Care Business
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Medical Devices10,000 affectedAug 14, 2024
High RiskFDA
Zoe Medical Incorporated
Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330
Medical Devices6,429 affectedAug 13, 2024
High RiskFDA
Olympus Corporation Of The Americas
Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of so...
Medical Devices1,373 affectedAug 13, 2024
High RiskFDA
Zoe Medical Incorporated
Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331
Medical Devices1,506 affectedAug 13, 2024
High RiskFDA
Merit Medical Systems, Inc.
Custom Procedure Kit, REF: K12T-11077
Medical Devices24 affectedAug 12, 2024
High RiskFDA
Seer Medical Pty Ltd
Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video EEG (vEEG) recor...
Medical Devices3,948 affectedAug 12, 2024
High RiskFDA
Murata Vios, Inc.
Vios Monitoring System Bedside Monitor Model BSM2050
Medical Devices50 affectedAug 9, 2024
High RiskFDA
Wipro Ge Healthcare Private Ltd.
GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1112198-01045579; 3) M1112198-01047148; 4) M1112198-01047...
Medical Devices137 affectedAug 9, 2024
High RiskFDA
Zimmer Gmbh
Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral an...
Medical Devices58 affectedAug 8, 2024
CriticalFDA
Datascope Corp.
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Medical Devices5,475 affectedAug 8, 2024
High RiskFDA
Orthoscan, Inc.
Ziehm Solo. Digital Mobile C-arm
Medical Devices28 affectedAug 8, 2024
High RiskFDA
Orthoscan, Inc.
Ziehm Solo FD. Interventional fluoroscopic x-ray system
Medical Devices25 affectedAug 8, 2024
High RiskFDA
Orthoscan, Inc.
Ziehm Vision RFD. Interventional fluoroscopic x-ray system
Medical Devices30 affectedAug 8, 2024
High RiskFDA
Alcon Research Llc
DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,
Medical Devices92,835 affectedAug 8, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013
Medical Devices6 affectedAug 8, 2024
CriticalFDA
Datascope Corp.
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Medical Devices5,475 affectedAug 8, 2024
High RiskFDA
Ge Healthcare Gmbh
ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; sys...
Medical Devices574 affectedAug 8, 2024
CriticalFDA
Datascope Corp.
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Medical Devices5,475 affectedAug 8, 2024
RecallFDA
T.g. Eakin Limited
eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal
Medical Devices35,400 affectedAug 8, 2024
High RiskFDA
Orthoscan, Inc.
Ziehm Vision system, x-ray, tomography, computed.
Medical Devices3 affectedAug 8, 2024
High RiskFDA
Orthoscan, Inc.
Ziehm Vision R. Iterventional fluoroscopic x-ray system
Medical Devices5 affectedAug 8, 2024
High RiskFDA
Cook Biotech, Inc.
Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias. Order Number ...
Medical Devices120 affectedAug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Hand Pack, AKHD97C; Medical convenience kit
Medical Devices2 affectedAug 7, 2024