Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 213 of 548
FDA Devices Moderate Jun 17, 2020
RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
RAYSEARCH LABORATORIES AB
FDA Devices Moderate Jun 17, 2020
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 7 HOLE 140MM, Item Number: 110030307 - Product Usage: Intended for temporary internal fixat…
Biomet
FDA Devices Moderate Jun 17, 2020
RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
RAYSEARCH LABORATORIES AB
FDA Devices Moderate Jun 17, 2020
Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) laboratorie…
Ventana Medical Systems Inc
FDA Devices Moderate Jun 17, 2020
RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radiation therapy and medical oncology which can also be used to administer …
RAYSEARCH LABORATORIES AB
FDA Devices Moderate Jun 17, 2020
A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Plate-Cage 32x21x15 7 A Link Z Ti Unitary Plate-Cage 32x21x1…
Acuity Surgical Devices, LLC
FDA Devices Moderate Jun 17, 2020
Genicon GENILook Model 200-105-151, 5mm diameter, 100mm length (one cannula) - Product Usage: The universal handle can be used as a pistol grip or …
Genicon, Inc.
FDA Devices Moderate Jun 17, 2020
Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UDI Number 00630414595580 use in the quantitative measurement of glycated …
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Jun 17, 2020
Genicon GENILook Model 200-005-151, 5mm diameter, 100mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol…
Genicon, Inc.
FDA Devices Moderate Jun 17, 2020
RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
RAYSEARCH LABORATORIES AB
FDA Devices Moderate Jun 17, 2020
Genicon Natura Model 210-105-251, 5mm diameter, 150mm length (1 cannula) - Product Usage: The universal handle can be used as a pistol grip or like…
Genicon, Inc.
FDA Devices Moderate Jun 17, 2020
Genicon GENILook Model 200-005-153; 5mm diameter, 100mm length (three cannula) - Product Usage: The universal handle can be used as a pistol grip o…
Genicon, Inc.
FDA Devices Moderate Jun 17, 2020
A.L.P.S. T15 LOW PROFILE CORTICAL SCREW 3.5mm x 28mm, Item Number: 110017628 - Product Usage: Intended for temporary internal fixation and stabiliza…
Biomet
FDA Devices Moderate Jun 17, 2020
Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diag…
Canon Medical System, USA, INC.
FDA Devices Moderate Jun 17, 2020
Biomet 8.0 Cannulated Screw Tap-Bone fixation screw Item Number: 110008467 - Product Usage: Intended for temporary internal fixation and stabilizati…
Biomet
FDA Devices Moderate Jun 17, 2020
Genicon Natura Model 210-005-051; 5mm diameter, 70mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol gr…
Genicon, Inc.
FDA Devices Moderate Jun 17, 2020
Genicon Natura Model 210-005-251, 5mm diameter, 150mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol g…
Genicon, Inc.
FDA Devices Moderate Jun 17, 2020
smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71332242…
Smith & Nephew, Inc.
FDA Devices Moderate Jun 17, 2020
Genicon Natura Model 210-005-151; 5mm diameter, 100mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a pistol g…
Genicon, Inc.
FDA Devices Moderate Jun 17, 2020
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 234MM Item Number: 110025473 - Product Usage: Intended for temporary int…
Biomet
FDA Devices Moderate Jun 17, 2020
Infinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diag…
Canon Medical System, USA, INC.
FDA Devices Moderate Jun 17, 2020
Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI: 00850291007079
INARI MEDICAL
FDA Devices Moderate Jun 17, 2020
Comprehensive VRS Inserter, shoulder prosthesis, Item No. 110019068. UDI: (01)00880304829503 (10)814100, (01)00880304829503 (10)570640, (01)0088030…
Biomet, Inc.
FDA Devices Critical Jun 17, 2020
Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-AB2380-I, TV-AB2380-J, TV-AB2680-I, TV-AB2680-J, TV-AB2980-I, TV-AB2980-J…
Endologix, Inc.
FDA Devices Moderate Jun 17, 2020
smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 48MM 7133873…
Smith & Nephew, Inc.
FDA Devices Moderate Jun 17, 2020
Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 00842768030512 - Product Usage: use in the quantitative determination of…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Jun 17, 2020
Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.
ROi CPS LLC
FDA Devices Moderate Jun 17, 2020
BD FACS Sample Prep Assistant (SPA) III - Product Usage: Prep Assistant III is intended to prepare human whole blood for flow cytometric analysis on …
Becton, Dickinson and Company, BD Biosciences
FDA Devices Moderate Jun 17, 2020
Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,a…
Immuno-Mycologics, Inc
FDA Devices Moderate Jun 17, 2020
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 11 HOLE 190MM, Item Number: 110030208 - Product Usage: Intended for temporary internal fix…
Biomet
CPSC Moderate Jun 17, 2020
Edwards Recalls Mechanical Heat Detectors Due to Failure to Alert to Fire
CPSC Moderate Jun 17, 2020
Republic Wireless Recalls Relay Charging Cables Due to Overheating and Burn Hazards
FDA Devices Moderate Jun 10, 2020
TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM - Product Usage: is intended for the quantitative measurement of glucose (sugar) in fresh capillary …
Trividia Health, Inc.
FDA Devices Moderate Jun 10, 2020
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X35MM, Item Number 810M5535 - Product Usage: are non-cervical spinal fixation devices …
Zimmer Biomet, Inc.
FDA Devices Moderate Jun 10, 2020
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X45MM, Item Number 810M4545 - Product Usage: are non-cervical spinal fixation devices …
Zimmer Biomet, Inc.
FDA Devices Low Jun 10, 2020
PerkinElmer 226 Sample Collection Device
PerkinElmer Health Sciences, Inc.
FDA Devices Moderate Jun 10, 2020
Sterile Custom Packs to be used in surgical procedures.
American Contract Systems
FDA Devices Moderate Jun 10, 2020
Sterile Custom Packs to be used in surgical procedures.
American Contract Systems
FDA Devices Moderate Jun 10, 2020
Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X55MM, Item Number 811M8555 - Product Usage: are non-cervical spinal fixation devices i…
Zimmer Biomet, Inc.
FDA Devices Moderate Jun 10, 2020
AC Powered hospital adjustable bed.
Umano Medical, Inc.
FDA Devices Moderate Jun 10, 2020
Sterile Custom Packs to be used in surgical procedures.
American Contract Systems
FDA Devices Moderate Jun 10, 2020
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X50MM, Item Number 810M5550 - Product Usage: are non-cervical spinal fixation devices …
Zimmer Biomet, Inc.
FDA Devices Moderate Jun 10, 2020
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X45MM, Item Number 810M5545 - Product Usage: are non-cervical spinal fixation devices …
Zimmer Biomet, Inc.
FDA Devices Moderate Jun 10, 2020
Beckman Coulter ACCESS Immunoassay Systems, Access Total T3 Triiodothyronine , REF 33830 (UDI: 15099590227210) for use with the Access Family of Im…
Beckman Coulter Inc.
FDA Devices Moderate Jun 10, 2020
Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysi…
Baxter Healthcare Corporation
FDA Devices Moderate Jun 10, 2020
Beckman Coulter ACCESS Immunoassay Systems, Access GI Monitor Cancer Antigen 19-9, REF 387687 ( UDI: 15099590231842) the Access Family of Immunoassa…
Beckman Coulter Inc.
FDA Devices Moderate Jun 10, 2020
Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X60MM, Item Number 811M8560 - Product Usage: are non-cervical spinal fixation devices i…
Zimmer Biomet, Inc.
FDA Devices Moderate Jun 10, 2020
safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1
Radiometer Medical ApS
FDA Devices Moderate Jun 10, 2020
OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product Usage: The product provides a bone void filler that is replaced by bone …
Osteomed, LLC
FDA Devices Moderate Jun 10, 2020
Pressure Monitoring Set, C-PMS, G02838
Cook Inc.