Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 196 of 548
FDA Devices Moderate Dec 2, 2020
ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Amperes - 21…
Viewray, Inc.
FDA Devices Moderate Dec 2, 2020
Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and period…
Geistlich Pharma North America, Inc.
FDA Devices Moderate Dec 2, 2020
Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the Ion Fully Articulating Catheter within the lung …
Intuitive Surgical, Inc.
FDA Devices Low Dec 2, 2020
AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 used to power the following devices: Na¿da CI Q90 Sound Processor (CI-528…
Advanced Bionics, LLC
FDA Devices Moderate Dec 2, 2020
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 26L - is a single use, disposable cryoprobe that is des…
MEDTRONIC ATS MEDICAL, INC.
FDA Devices Moderate Dec 2, 2020
ViewRay MRIdian Linac System: Model No. 20000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Ampere…
Viewray, Inc.
FDA Devices Moderate Dec 2, 2020
RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0 -…
RAYSEARCH LABORATORIES AB
FDA Devices Moderate Dec 2, 2020
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: is a single use, disposable cryopro…
MEDTRONIC ATS MEDICAL, INC.
FDA Devices Moderate Dec 2, 2020
Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC…
Luminex Corporation
FDA Devices Moderate Dec 2, 2020
Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for impla…
Coloplast Manufacturing US, LLC
FDA Devices Moderate Dec 2, 2020
MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treatment to patients with localiz…
Mevion Medical Systems, Inc.
FDA Devices Moderate Dec 2, 2020
Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC…
Luminex Corporation
FDA Devices Low Dec 2, 2020
AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the following devices: Na¿da CI Q90 Sound Processor (CI-528…
Advanced Bionics, LLC
FDA Devices Moderate Dec 2, 2020
iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replacement components as well as t…
Conformis, Inc.
FDA Devices Moderate Dec 2, 2020
Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor, Model MS-01-0118 - Product Usage: use in home and institutional s…
Hill-Rom Manufacturing, Inc.
FDA Devices Moderate Nov 25, 2020
Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Produc…
Mako Surgical Corporation
FDA Devices Moderate Nov 25, 2020
Elastic Traction Device, 11mm Lower. UPN: ER56041 Reference Number: ETD-D-26-235-C-N - Product Usage: indicated for use in flexible Endoscopy to pro…
Micro-Tech Usa
FDA Devices Moderate Nov 25, 2020
VNS Therapy¿ AspireSR¿ Generator
LivaNova USA Inc
FDA Devices Moderate Nov 25, 2020
CEI Cutting Edge Instruments (PTC-57C)
Coltene Whaledent Inc
FDA Devices Moderate Nov 25, 2020
Osteosynthesis Compression Staple EasyClip
Stryker GmbH
FDA Devices Moderate Nov 25, 2020
FG 57 100057X (100057X)
Coltene Whaledent Inc
FDA Devices Moderate Nov 25, 2020
Class IV New Era medical laser device
Inova Lasers LLC
FDA Devices Moderate Nov 25, 2020
Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
Exactech, Inc.
FDA Devices Moderate Nov 25, 2020
Alpen Clinic 100 Carbide Instruments (R100057C)
Coltene Whaledent Inc
FDA Devices Moderate Nov 25, 2020
v|tome|x L Series non-destructive testing cabinet x-ray systems
Ge Inspection Technologies Llc
FDA Devices Moderate Nov 25, 2020
Kangaroo Connect 1000ml Bag Set, Non-Sterile, Product Code 77100FD - Product Usage: single-use tubing sets used with pumps in the delivery of nutriti…
Cardinal Health 200, LLC
FDA Devices Moderate Nov 25, 2020
VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in monitoring the performance of the VITROS Immunodiagnostic a…
Ortho Clinical Diagnostics Inc
FDA Devices Moderate Nov 25, 2020
MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1 unit - (01)00884450491102, 25…
Merit Medical Systems, Inc.
FDA Devices Moderate Nov 25, 2020
Merit Medical Cultura Collection and Transport System, Ref CFTS100, Single Use, IVD, for the following unit counts: 1 Unit - (01)00884450492123, 50 U…
Merit Medical Systems, Inc.
FDA Devices Moderate Nov 25, 2020
Clinic Pack 100 Pieces FG 57 100057C (100057C)
Coltene Whaledent Inc
FDA Devices Moderate Nov 25, 2020
Kangaroo Connect 500ml Bag Set, Non-Sterile, Product Code 77500FD - Product Usage: single-use tubing sets used with pumps in the delivery of nutritio…
Cardinal Health 200, LLC
FDA Devices Moderate Nov 25, 2020
VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adapt…
Ortho Clinical Diagnostics Inc
FDA Devices Moderate Nov 25, 2020
COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns in diameter of calcium hydrox…
Merz North America, Inc.
FDA Devices Moderate Nov 25, 2020
Merit Medical Cultura Collection and Transport System, 3 mL Viral Transport Medium, Ref: VCTS100, Single Use, IVD, for the following unit counts: 1 U…
Merit Medical Systems, Inc.
FDA Devices Moderate Nov 25, 2020
Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.
Thomas Scientific
FDA Devices Moderate Nov 25, 2020
cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configuration and c…
Roche Diagnostics Operations, Inc.
FDA Devices Moderate Nov 18, 2020
Accelerator a3600 Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a …
Inpeco S.A.
FDA Devices Moderate Nov 18, 2020
Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Nov 18, 2020
SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt - Product Usage: intended for use in the dermatologic and surgical procedures for electr…
Aesthetics Biomedical, Inc.
FDA Devices Low Nov 18, 2020
XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Sterile R, Single Use Only, for the following Reference numbers/ Primary DI N…
XTANT Medical
FDA Devices Moderate Nov 18, 2020
EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qualitative detection of human anti-COVID-19 IgG a…
Epitope Diagnostics, Inc.
FDA Devices Moderate Nov 18, 2020
AMS 700 MS Pump with and without InhibiZone, sold as individual units and also pre-connected to AMS 700 cylinders. Inflatable Penile Prosthesis
Boston Scientific Corporation
FDA Devices Moderate Nov 18, 2020
Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on patient population sizes from Neonatal (NICU) through Adult who require res…
Covidien Llc
FDA Devices Low Nov 18, 2020
Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499
Hardy Diagnostics
FDA Devices Moderate Nov 18, 2020
Aptio Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular syst…
Inpeco S.A.
FDA Devices Moderate Nov 18, 2020
Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be operated by…
Shanghai United Imaging Healthcare Co., Ltd.
FDA Devices Moderate Nov 18, 2020
Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - Product Usage: ntended to produce cross-sectional images of the body…
Shanghai United Imaging Healthcare Co., Ltd.
FDA Devices Moderate Nov 18, 2020
QUIDEL Sofia SARS Antigen FIA IVD REF 20374
Quidel Corporation
FDA Devices Moderate Nov 18, 2020
Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 06971576831036 - Product Usage: ntended to produce cross-sectional images of the body…
Shanghai United Imaging Healthcare Co., Ltd.
FDA Devices Moderate Nov 18, 2020
Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 06971576831012 - Product Usage: ntended to produce cross-sectional images of the body…
Shanghai United Imaging Healthcare Co., Ltd.