Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Xcision Medical Systems, Llc
GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product Usage: GammaPod is a teletherapy device intended for...
Medical Devices·2 affected·Jul 3, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Drive, Model Number 10431700 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images...
Medical Devices·0 affected·Jul 3, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Force, Model Number 10742326 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images...
Medical Devices·0 affected·Jul 3, 2019
High RiskFDA
Valeritas, Incorporated
DEMO No Needle Corrugated Carton 30 U/D, Part Number 2568-02
Medical Devices·60 affected·Jul 3, 2019
High RiskFDA
Capso Vision, Inc.
CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF 2795 - Product Usage: The Caps...
Medical Devices·44 affected·Jul 3, 2019
High RiskFDA
Valeritas, Incorporated
DEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01
Medical Devices·21,714 affected·Jul 3, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Edge Plus, Model Number 10267000 - Product Usage: Computed tomography systems intended to generate and process cross-sectional im...
Medical Devices·0 affected·Jul 3, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition Edge, Model Number 10590000 - Product Usage: Computed tomography systems intended to generate and process cross-sectio...
Medical Devices·0 affected·Jul 3, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition Flash, Model Number 10430603 - Product Usage: Computed tomography systems intended to generate and process cross-secti...
Medical Devices·0 affected·Jul 3, 2019
High RiskFDA
Pedialift Llc
PediaLift Access Device, Device Identifier: B751PDLFT0
Medical Devices·11 affected·Jul 3, 2019
High RiskFDA
Zimmer Biomet, Inc.
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151812
Medical Devices·23 affected·Jul 2, 2019
High RiskFDA
Cincinnati Sub-zero Products Llc, A Gentherm Company
CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product Usage: The system is composed of a heater, a compr...
Medical Devices·5,291 affected·Jul 2, 2019
High RiskFDA
Zimmer Biomet, Inc.
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151811
Medical Devices·28 affected·Jul 2, 2019
High RiskFDA
Qiagen Sciences Llc
QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is designed to perform automate...
Medical Devices·417 affected·Jul 2, 2019
High RiskFDA
Cincinnati Sub-zero Products Llc, A Gentherm Company
Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The system is compos...
Medical Devices·3,932 affected·Jul 2, 2019
High RiskFDA
Zimmer Biomet, Inc.
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151815
Medical Devices·19 affected·Jul 2, 2019
High RiskFDA
Zimmer Biomet, Inc.
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151810
Medical Devices·29 affected·Jul 2, 2019
High RiskFDA
Ge Healthcare, Llc
Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D
Medical Devices·3 affected·Jul 2, 2019
High RiskFDA
Zimmer Biomet, Inc.
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151813
Medical Devices·39 affected·Jul 2, 2019
High RiskFDA
Mazor Robotics Ltd
Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868
Medical Devices·93 affected·Jul 2, 2019
High RiskFDA
Ge Healthcare, Llc
Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D
Medical Devices·2 affected·Jul 2, 2019
High RiskFDA
Zimmer Biomet, Inc.
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151814
Medical Devices·30 affected·Jul 2, 2019
High RiskFDA
Centurion Medical Products Corporation
DRIVELINE MANAGEMENT SYSTEM 1 DAILY Kit Code: DT18440A - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for ...
Medical Devices·6,180 affected·Jul 1, 2019
High RiskFDA
Centurion Medical Products Corporation
DAILY DRIVELINE KIT Kit Code: DM940 - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient pop...
Medical Devices·3,250 affected·Jul 1, 2019
High RiskFDA
Centurion Medical Products Corporation
CIRCUMCISION TRAY Kit Code: CIT2245 - Product Usage: Kit is used for performing circumcision procedures on newborns.
Medical Devices·220 affected·Jul 1, 2019
High RiskFDA
Centurion Medical Products Corporation
STERILE GRAVES VAGINAL SPECULUM MEDIUM Kit Code # GVS10MST - Product Usage:The speculum is used to spread the walls of the vagina to faci...
Medical Devices·2,019,041,790 affected·Jul 1, 2019
High RiskFDA
Privapath Diagnostics Ltd
Universal Sexual Health Testing Kit
Medical Devices·0 affected·Jul 1, 2019
High RiskFDA
Centurion Medical Products Corporation
LACERATION TRAY Kit Code: SUT18370 - Product Usage: Kit is used for laceration repairs for general population.
Medical Devices·3,804 affected·Jul 1, 2019
High RiskFDA
Centurion Medical Products Corporation
SNAG FREE SUTURE TRAY Kit Code: SUT14355 - Product Usage: Kit is used for laceration repairs for general population.
Medical Devices·48 affected·Jul 1, 2019
High RiskFDA
Centurion Medical Products Corporation
UNIVERSAL BLOCK TRAY Kit Code: MNS6645 - Product Usage: Kit is used for regional anesthesia nerve blocks for general population.
Medical Devices·4,560 affected·Jul 1, 2019
High RiskFDA
Centurion Medical Products Corporation
DRIVELINE MANAGEMENT TRAY Kit Code: DT17780B - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general pa...
Medical Devices·1,900 affected·Jul 1, 2019
High RiskFDA
Teleflex Medical
Rusch EasyCath Kit
Medical Devices·3,700 affected·Jul 1, 2019
RecallFDA
Clariance Inc
Erisma- LP posterior fixation system with the below specifically affected products: 1. Erisma-LP polyaxial screws - 4.5, 5.5, 6.5, 7...
Medical Devices·4,090 affected·Jul 1, 2019
High RiskFDA
Centurion Medical Products Corporation
NEONATAL PICC INSERTION TRAY Kit Code: CVI2310 - Product Usage: Kit is used for Peripheral Central Line Insertion procedures on newborns.
Medical Devices·120 affected·Jul 1, 2019
High RiskFDA
Centurion Medical Products Corporation
LVAD DRESSING SYSTEM W/BIOPATCHKit Code: DM700 - Product Usage: Kit is used for Left Ventricular Assist Device Dressing System for genera...
Medical Devices·1,224 affected·Jul 1, 2019
High RiskFDA
Centurion Medical Products Corporation
HIGH DRAINAGE LVAD TRAY Kit Code: DM950 - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient...
Medical Devices·192 affected·Jul 1, 2019
High RiskFDA
Ge Healthcare, Llc
MAC VU360, Model Number 2030360-001, Electrocardiograph
Medical Devices·369 affected·Jun 28, 2019
High RiskFDA
Sentinel Ch Spa
MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity...
Medical Devices·15,919 affected·Jun 28, 2019
CriticalFDA
Intellijoint Surgical, Inc.
Workstation, G2, Configured (P/N 000-0241)
Medical Devices·23 affected·Jun 28, 2019
High RiskFDA
Inter-med Llc
Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350
Medical Devices·768 affected·Jun 27, 2019
High RiskFDA
Medicrea International
Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PEDICULAIRE POLYAXIALE 7.5MM x 45MM, POLYAXIAL PEDICLE SCREW 7...
Medical Devices·210 affected·Jun 27, 2019
High RiskFDA
Agfa N.v.
AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 800 system is indicated for performing...
Medical Devices·4 affected·Jun 27, 2019
High RiskFDA
Inter-med Llc
Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 502315
Medical Devices·582 affected·Jun 27, 2019
High RiskFDA
Inter-med Llc
Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355
Medical Devices·445 affected·Jun 27, 2019
High RiskFDA
Baxter Healthcare Corporation
EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, REF H9388505, x500 PHARMACY PACK, REF H9388105, x100 COST CONTAINMENT, REF H938...
Medical Devices·2,192,000 affected·Jun 27, 2019
High RiskFDA
Inter-med Llc
Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300
Medical Devices·1,992 affected·Jun 27, 2019
High RiskFDA
Microaire Surgical Instruments, Llc
SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014
Medical Devices·103 affected·Jun 26, 2019
High RiskFDA
Deerfield Imaging, Inc.
IMRIS MR/X-ray head fixation device, Model HFD200
Medical Devices·3 affected·Jun 26, 2019