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15,654 recalls
High RiskFDA
Change Healthcare Canada Company
Horizon Cardiology Hemo. Version 12.2.
Medical Devices·3 affected·Aug 21, 2024
CriticalFDA
Baxter Healthcare Corporation
Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
Medical Devices·2,140,046 affected·Aug 20, 2024
CriticalFDA
Baxter Healthcare Corporation
Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device
Medical Devices·1,548,782 affected·Aug 20, 2024
CriticalFDA
Baxter Healthcare Corporation
Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
Medical Devices·5,828,540 affected·Aug 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 Devices·16,439 affected·Aug 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 Devices·7,099 affected·Aug 19, 2024
High RiskFDA
Merit Medical Systems, Inc.
basixSKY Inflation Device, REF: SKY1802
Medical Devices·70 affected·Aug 19, 2024
High RiskFDA
Merit Medical Systems, Inc.
MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B
Medical Devices·12,910 affected·Aug 19, 2024
High RiskFDA
Merit Medical Systems, Inc.
DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A
Medical Devices·290 affected·Aug 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 Devices·14,120 affected·Aug 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 Devices·60 affected·Aug 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 Devices·40 affected·Aug 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 Devices·642 affected·Aug 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 Devices·180 affected·Aug 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 Devices·894 affected·Aug 16, 2024
High RiskFDA
Carefusion 303, Inc.
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
Medical Devices·180 affected·Aug 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 Devices·10,658,351 affected·Aug 15, 2024
High RiskFDA
Carefusion 303, Inc.
Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
Medical Devices·192,964 affected·Aug 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 Devices·4,984,920 affected·Aug 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 Devices·4,671,540 affected·Aug 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 Devices·9,864,165 affected·Aug 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 Devices·142,336 affected·Aug 15, 2024
High RiskFDA
Carefusion 303, Inc.
Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
Medical Devices·10,460 affected·Aug 15, 2024
High RiskFDA
Carefusion 303, Inc.
Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system
Medical Devices·125,017 affected·Aug 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 Devices·568 affected·Aug 14, 2024
High RiskFDA
3m Company - Health Care Business
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Medical Devices·10,000 affected·Aug 14, 2024
High RiskFDA
Zoe Medical Incorporated
Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330
Medical Devices·6,429 affected·Aug 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 Devices·1,373 affected·Aug 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 Devices·1,506 affected·Aug 13, 2024
High RiskFDA
Merit Medical Systems, Inc.
Custom Procedure Kit, REF: K12T-11077
Medical Devices·24 affected·Aug 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 Devices·3,948 affected·Aug 12, 2024
High RiskFDA
Murata Vios, Inc.
Vios Monitoring System Bedside Monitor Model BSM2050
Medical Devices·50 affected·Aug 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 Devices·137 affected·Aug 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 Devices·58 affected·Aug 8, 2024
CriticalFDA
Datascope Corp.
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Medical Devices·5,475 affected·Aug 8, 2024
High RiskFDA
Orthoscan, Inc.
Ziehm Solo. Digital Mobile C-arm
Medical Devices·28 affected·Aug 8, 2024
High RiskFDA
Orthoscan, Inc.
Ziehm Solo FD. Interventional fluoroscopic x-ray system
Medical Devices·25 affected·Aug 8, 2024
High RiskFDA
Orthoscan, Inc.
Ziehm Vision RFD. Interventional fluoroscopic x-ray system
Medical Devices·30 affected·Aug 8, 2024
High RiskFDA
Alcon Research Llc
DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,
Medical Devices·92,835 affected·Aug 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 Devices·6 affected·Aug 8, 2024
CriticalFDA
Datascope Corp.
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Medical Devices·5,475 affected·Aug 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 Devices·574 affected·Aug 8, 2024
CriticalFDA
Datascope Corp.
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Medical Devices·5,475 affected·Aug 8, 2024
RecallFDA
T.g. Eakin Limited
eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal
Medical Devices·35,400 affected·Aug 8, 2024
High RiskFDA
Orthoscan, Inc.
Ziehm Vision system, x-ray, tomography, computed.
Medical Devices·3 affected·Aug 8, 2024
High RiskFDA
Orthoscan, Inc.
Ziehm Vision R. Iterventional fluoroscopic x-ray system
Medical Devices·5 affected·Aug 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 Devices·120 affected·Aug 7, 2024
High RiskFDA
American Contract Systems, Inc.
Hand Pack, AKHD97C; Medical convenience kit
Medical Devices·2 affected·Aug 7, 2024