Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Biomet 3i, Llc
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564
Medical Devices·0 affected·Jan 10, 2020
High RiskFDA
Biomet 3i, Llc
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA563
Medical Devices·0 affected·Jan 10, 2020
High RiskFDA
Biomet 3i, Llc
CERTAIN¿ BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H) Reference Number: IEHA344
Medical Devices·0 affected·Jan 10, 2020
High RiskFDA
Biomet 3i, Llc
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 6MM(H) Reference Number: IEHA446
Medical Devices·0 affected·Jan 10, 2020
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 - Product Usage: is indicated for use for up to 6 hours in th...
Medical Devices·11 affected·Jan 10, 2020
High RiskFDA
Biomet 3i, Llc
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 3MM(H) Reference Number: IEHA553
Medical Devices·0 affected·Jan 10, 2020
High RiskFDA
Biomet 3i, Llc
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(H) Reference Number: IEHA443
Medical Devices·0 affected·Jan 10, 2020
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 Roller Pump, 4 Inch, Catalog Number 816570 - Product Usage: is indicated for use for up to 6 hours in ...
Medical Devices·33 affected·Jan 10, 2020
High RiskFDA
Biomet 3i, Llc
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 4MM(H) Reference Number: IEHA554
Medical Devices·0 affected·Jan 10, 2020
High RiskFDA
Teleflex Medical Inc
Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System
Medical Devices·338,928 affected·Jan 9, 2020
High RiskFDA
Teleflex Medical Inc
Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System
Medical Devices·338,928 affected·Jan 9, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS Healthineers Uroskop Omnia max Model: 10762473 - Product Usage: is a device intended to visualize anatomical structures by conv...
Medical Devices·194 affected·Jan 8, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Model: 10762470 - Product Usage: is a device intended to visua...
Medical Devices·512 affected·Jan 8, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ys...
Medical Devices·507 affected·Jan 8, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS Healthineers Luminos Agile Max Model: 10762472 - Product Usage: is a device intended to visualize anatomical structures by conv...
Medical Devices·477 affected·Jan 8, 2020
High RiskFDA
Zimmer Biomet, Inc.
THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14-451090 14-451095 14-451100 14-451105 14-451110 14-4...
Medical Devices·1,662 affected·Jan 7, 2020
High RiskFDA
Palodex Group Oy
Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
Medical Devices·4,563 affected·Jan 7, 2020
High RiskFDA
Palodex Group Oy
Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
Medical Devices·101 affected·Jan 7, 2020
High RiskFDA
Smiths Medical Asd, Inc.
Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes
Medical Devices·127,700 affected·Jan 7, 2020
CriticalFDA
Cme America, Llc
CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress
Medical Devices·30,596 affected·Jan 7, 2020
High RiskFDA
Stryker Corporation
Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/ 10858701006282
Medical Devices·26,298 affected·Jan 7, 2020
High RiskFDA
Smiths Medical Asd, Inc.
Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes
Medical Devices·720,100 affected·Jan 7, 2020
High RiskFDA
Palodex Group Oy
Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
Medical Devices·297 affected·Jan 7, 2020
High RiskFDA
Medline Industries Inc
Medline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in Malaysia APPLICATOR:Made in China STERILE (01)40889942587583(10...
Medical Devices·500 affected·Jan 7, 2020
High RiskFDA
Medtech Sas
ROSA Brain 3.0 Application-Brain
Medical Devices·47 affected·Jan 6, 2020
High RiskFDA
Medtech Sas
ROSA One 3.1 Brain Application
Medical Devices·39 affected·Jan 6, 2020
High RiskFDA
Bard Peripheral Vascular Inc
Bard Biopsy EnCor Probe, MRI, 10G Trocar Tip, REF number ECPMR0110G, packaged individually in sterile pouches, 5 pouches/carton, Single U...
Medical Devices·2,050 affected·Jan 3, 2020
High RiskFDA
Depuy Orthopaedics, Inc.
SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block.
Medical Devices·140 affected·Jan 3, 2020
High RiskFDA
Microbiologics Inc
Vaginal Verification Panel Ref 8208 Lot 8208-11
Medical Devices·9 affected·Jan 3, 2020
High RiskFDA
Zimmer Surgical Inc
Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual Bladder, Item No. 60708015200, UDI (01)00889...
Medical Devices·58 affected·Jan 3, 2020
High RiskFDA
Clinical Diagnostic Solutions, Inc.
Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011
Medical Devices·261 affected·Jan 2, 2020
High RiskFDA
Koios Medical, Inc.
Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images.
Medical Devices·10 affected·Dec 31, 2019
High RiskFDA
Philips North America, Llc
Integris Allura 9, system codes 722018 722021
Medical Devices·20 affected·Dec 30, 2019
High RiskFDA
Philips North America, Llc
Cardio Vascular-Allura Centron, system code 722400
Medical Devices·87 affected·Dec 30, 2019
High RiskFDA
Philips North America, Llc
Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044)
Medical Devices·70 affected·Dec 30, 2019
High RiskFDA
Smith & Nephew, Inc.
TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.
Medical Devices·82 affected·Dec 30, 2019
High RiskFDA
Philips North America, Llc
Poly G Integris H5000, System code 72246
Medical Devices·1 affected·Dec 30, 2019
High RiskFDA
Wright Medical Technology, Inc.
WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220
Medical Devices·39 affected·Dec 27, 2019
High RiskFDA
Wright Medical Technology, Inc.
WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222
Medical Devices·48 affected·Dec 27, 2019
High RiskFDA
Cardinal Health Inc.
Kangaroo Connect ENPlus Spike Set Anti-free Flow, Product Code 77000FD
Medical Devices·114,731 affected·Dec 26, 2019
High RiskFDA
Cardinal Health Inc.
Kangaroo 924 Safety Screw Spike Set, Product Code 775759
Medical Devices·114,731 affected·Dec 26, 2019
High RiskFDA
Cardinal Health Inc.
Kangaroo Epump Safety Screw Spike with Flush Bag, Anti-free Flow, 1000 mL, Product Code 775100
Medical Devices·114,731 affected·Dec 26, 2019
High RiskFDA
Jjgc Industria E Comercio De Materials Dentarios Sa
Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr.
Medical Devices·2 affected·Dec 23, 2019
High RiskFDA
Nikon Metrology
Nikon Metrology XTH cabinet x-ray Systems which includes variations STH225, XTH225ST, and MCT225.
Medical Devices·110 affected·Dec 23, 2019
High RiskFDA
Carroll-baccari, Inc.
LemonPrep Tubes (MD0019-T) and Single use cups (MD0019-SUP)
Medical Devices·8,030 affected·Dec 23, 2019
High RiskFDA
Ge Healthcare, Llc
SIGNA Architect Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support...
Medical Devices·62 affected·Dec 23, 2019
High RiskFDA
Ge Healthcare, Llc
SIGNA Pioneer Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support h...
Medical Devices·62 affected·Dec 23, 2019
High RiskFDA
Ge Healthcare, Llc
SIGNA Premier Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support h...
Medical Devices·62 affected·Dec 23, 2019