Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 175 of 548
FDA Devices Moderate Jul 14, 2021
Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024
Luminex Corporation
FDA Devices Moderate Jul 14, 2021
Sterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525 - Product Usage: intended to be used as protective patient coverings, such …
Cardinal Health 200, LLC
FDA Devices Moderate Jul 14, 2021
Nonsterile Femoral Angiography Drape, Catalog Numbers: a) 29460NB, b) 29456NB - Product Usage: intended to be used as protective patient coverings, s…
Cardinal Health 200, LLC
FDA Devices Moderate Jul 14, 2021
Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066001
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Jul 14, 2021
HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
LIEBEL-FLARSHEIM COMPANY LLC
FDA Devices Moderate Jul 14, 2021
Nonsterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525N - Product Usage: intended to be used as protective patient coverings, s…
Cardinal Health 200, LLC
FDA Devices Moderate Jul 14, 2021
Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
Randox Laboratories Ltd.
FDA Devices Moderate Jul 14, 2021
Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021
Luminex Corporation
FDA Devices Moderate Jul 14, 2021
CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16;
Medtronic Heart Valves Division
FDA Devices Moderate Jul 14, 2021
VALITUDE CRT-P pacemaker, Models: a) U125 b) U128
Boston Scientific Corporation
FDA Devices Moderate Jul 14, 2021
Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722
Boston Scientific Corporation
FDA Devices Moderate Jul 14, 2021
The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry analyzer that runs tests on ser…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Jul 14, 2021
Nonsterile Radial/Femoral Angiography Drape, Catalog Number 29529N - Product Usage: intended to be used as protective patient coverings, such as to i…
Cardinal Health 200, LLC
FDA Devices Moderate Jul 14, 2021
Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023
Luminex Corporation
FDA Devices Moderate Jul 14, 2021
Sterile Femoral Angiography Drape, Catalog Numbers: a) 29460, b) 29456 - Product Usage: intended to be used as protective patient coverings, such as…
Cardinal Health 200, LLC
FDA Devices Moderate Jul 14, 2021
ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Jul 14, 2021
Revolution CT
GE Healthcare, LLC
FDA Devices Moderate Jul 14, 2021
Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022
Luminex Corporation
FDA Devices Moderate Jul 14, 2021
CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L; ENVEOR-N;
Medtronic Heart Valves Division
FDA Devices Moderate Jul 7, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT
Philips North America Llc
FDA Devices Moderate Jul 7, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882446 - Vereos PET/CT
Philips North America Llc
FDA Devices Critical Jul 7, 2021
LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
Magellan Diagnostics, Inc.
FDA Devices Moderate Jul 7, 2021
Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide…
Edwards Lifesciences, LLC
FDA Devices Moderate Jul 7, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems: Model - MX8000 Mod…
Philips North America Llc
FDA Devices Moderate Jul 7, 2021
Synaptive Trackable Suction Set Standard and Malleable
Synaptive Medical Inc
FDA Devices Moderate Jul 7, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728333 - Spectral CT:
Philips North America Llc
FDA Devices Moderate Jul 7, 2021
Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)57460691950547
Edwards Lifesciences, LLC
FDA Devices Critical Jul 7, 2021
LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004
Magellan Diagnostics, Inc.
FDA Devices Critical Jul 7, 2021
Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent
Quidel Corporation
FDA Devices Moderate Jul 7, 2021
5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC REF CK000340B BARD MYPICC KIT 5F French Size Du…
Bard Access Systems Inc.
FDA Devices Moderate Jul 7, 2021
Revolution EVO, Optima CT660, Optima CT680 CT Systems.
GE Healthcare, LLC
FDA Devices Moderate Jul 7, 2021
Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. Product Usage: in…
Remote Diagnostic Technologies Ltd.
FDA Devices Moderate Jul 7, 2021
SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lea…
Spes Medica
FDA Devices Moderate Jul 7, 2021
Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
Medtronic Vascular, Inc.
FDA Devices Moderate Jul 7, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. Brilliance 64, Brill…
Philips North America Llc
FDA Devices Moderate Jul 7, 2021
Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference Numbers LSE4246MCA075 and LSE500M. for continuous EMG monit…
Spes Medica
FDA Devices Moderate Jul 7, 2021
Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring.
Spes Medica
FDA Devices Moderate Jul 7, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. Brilliance 16 Powe…
Philips North America Llc
FDA Devices Moderate Jul 7, 2021
NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
NeuMoDx Molecular Inc
FDA Devices Moderate Jul 7, 2021
Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691944782
Edwards Lifesciences, LLC
FDA Devices Moderate Jul 7, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and MX16 Models: 728131
Philips North America Llc
FDA Devices Moderate Jul 7, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity C…
Philips North America Llc
FDA Devices Moderate Jun 30, 2021
Hays Ultrasound kit Item ID: H1000SE
Exact Medical Manufacturing, Inc.
FDA Devices Moderate Jun 30, 2021
6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852NA
Exact Medical Manufacturing, Inc.
FDA Devices Moderate Jun 30, 2021
Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744
Beckman Coulter Inc.
FDA Devices Moderate Jun 30, 2021
Probe Cover, PE, Elastic Bands, 15x244cm-6"x96" -Ultrasonic Transducer Cover Item ID: 1006576
Exact Medical Manufacturing, Inc.
FDA Devices Moderate Jun 30, 2021
OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326
Cardinal Health Inc.
FDA Devices Moderate Jun 30, 2021
Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-0…
Ventec Life Systems, Inc.
FDA Devices Critical Jun 30, 2021
GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860
Vero Biotech, LLC
FDA Devices Moderate Jun 30, 2021
Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N
Exact Medical Manufacturing, Inc.