Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Procept Biorobotics Corporation
AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of AquaBeam Robotic System. 320301 distributed outside the...
Medical Devices·214 affected·Mar 6, 2019
High RiskFDA
Becton Dickinson & Company
Gravity IV Set with 3-port Closed Stopcock Manifold Model CM42500E-07
Medical Devices·21,220 affected·Mar 5, 2019
High RiskFDA
Viewray, Inc.
MRIdian Linac Radiation Therapy System Model 10000 and 20000
Medical Devices·24 affected·Mar 3, 2019
High RiskFDA
Medical Action Industries Inc
Laparotomy Sponge with the following product description and model numbers: 1. Lap 18X18 XR (5 each/pack, 20 pack/case) - Model Num...
Medical Devices·228,300 affected·Mar 1, 2019
CriticalFDA
Becton Dickinson & Company
SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696
Medical Devices·2,900 affected·Feb 28, 2019
CriticalFDA
Brainlab Ag
Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended Use The Spine ...
Medical Devices·148 affected·Feb 27, 2019
High RiskFDA
Zevex Incorporated (dba Moog Medical Devices Group)
MOOG Curlin Infusion Administration Set, REF 340-4130, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter, packaged 2...
Medical Devices·569 affected·Feb 27, 2019
High RiskFDA
Zevex Incorporated (dba Moog Medical Devices Group)
MOOG Curlin Infusion Administration Set, REF 340-4130-V, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter with add-...
Medical Devices·756 affected·Feb 27, 2019
RecallFDA
Nidek, Inc.
NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium...
Medical Devices·13 affected·Feb 25, 2019
RecallFDA
Ge Healthcare, Llc
Integrated ECG cable with 3-lead leadwires labeled as the following: 1. ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, AHA,...
Medical Devices·288 affected·Feb 22, 2019
High RiskFDA
Luminex Molecular Diagnostics
xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple viral, bacterial ...
Medical Devices·965 affected·Feb 22, 2019
High RiskFDA
Arthrocare Corporation
Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971
Medical Devices·15,559 affected·Feb 21, 2019
CriticalFDA
Icu Medical, Inc.
icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) (b) REF CL-80S-5 (5 units). Used in IV administration s...
Medical Devices·23,800 affected·Feb 21, 2019
CriticalFDA
Icu Medical, Inc.
SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. Used in IV administration sets. The ChemoClave is a needle-free Closed Syste...
Medical Devices·3,500 affected·Feb 21, 2019
CriticalFDA
Icu Medical, Inc.
icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. Used in IV administration sets. The ChemoClave is a needle-free Closed Sy...
Medical Devices·60,500 affected·Feb 21, 2019
CriticalFDA
Icu Medical, Inc.
icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration sets. The ChemoClave is a needle-free Closed S...
Medical Devices·27,200 affected·Feb 21, 2019
CriticalFDA
Icu Medical, Inc.
icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave...
Medical Devices·300 affected·Feb 21, 2019
High RiskFDA
Smith & Nephew, Inc.
smith&nephew SMF(TM) HIGH OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1H SIZE, STEM, REF 713552511
Medical Devices·9 affected·Feb 19, 2019
High RiskFDA
Smith & Nephew, Inc.
smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510
Medical Devices·58 affected·Feb 19, 2019
High RiskFDA
Tedan Surgical Innovations Llc
D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Scre...
Medical Devices·199 affected·Feb 18, 2019
High RiskFDA
Tedan Surgical Innovations Llc
DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and ...
Medical Devices·57 affected·Feb 18, 2019
High RiskFDA
Covidien Llc
Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736
Medical Devices·25 affected·Feb 15, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spiral Dual Energy scan mode), Model Number 8098027 Product Us...
Medical Devices·53 affected·Feb 14, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomography systems intended to generate and process cross-sectional...
Medical Devices·53 affected·Feb 14, 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-sect...
Medical Devices·53 affected·Feb 14, 2019
High RiskFDA
Bioventus, Llc
BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device intended for use in bony voids or gaps that are not intrinsic to ...
Medical Devices·10,793 affected·Feb 13, 2019
High RiskFDA
Ge Healthcare, Llc
Discovery Ml DR Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (...
Medical Devices·1,113 affected·Feb 12, 2019
High RiskFDA
Ge Healthcare, Llc
Discovery Ml Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET...
Medical Devices·1,113 affected·Feb 12, 2019
High RiskFDA
Smiths Medical Asd Inc.
Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: ...
Medical Devices·7,840 affected·Feb 11, 2019
High RiskFDA
Fenwal Inc
Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autotransfusion System) is indicated for the processing of blood ...
Medical Devices·198 affected·Feb 11, 2019
High RiskFDA
Smiths Medical Asd Inc.
Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile Product Usage: Is a disposable, single use...
Medical Devices·109,000 affected·Feb 11, 2019
High RiskFDA
Terumo Medical Corporation
Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280
Medical Devices·563,000 affected·Feb 8, 2019
High RiskFDA
Terumo Medical Corporation
Terumo Needle, 23G x 1", Product Code NN2325R
Medical Devices·30,000 affected·Feb 8, 2019
High RiskFDA
Terumo Medical Corporation
Terumo Sur-vet Needle, 20G x 1", Product Code 100204
Medical Devices·729,000 affected·Feb 8, 2019
High RiskFDA
Terumo Medical Corporation
Terumo Sur-vet Needle, 22G x 1", Product Code 100211
Medical Devices·444,000 affected·Feb 8, 2019
High RiskFDA
Terumo Medical Corporation
Terumo Sur-vet Needle, 22G x 3/4", Product Code 100215
Medical Devices·638,000 affected·Feb 8, 2019
High RiskFDA
Elekta, Inc.
Monaco Radiation Treatment Planning (RTP) System
Medical Devices·14 affected·Feb 8, 2019
High RiskFDA
Terumo Medical Corporation
Terumo Needle, 18G x 1", Product Code NN1825R
Medical Devices·810,000 affected·Feb 8, 2019
High RiskFDA
Terumo Medical Corporation
Terumo Needle, 30G x 1/2", Product Code NN3013R
Medical Devices·81,000 affected·Feb 8, 2019
High RiskFDA
Lw Scientific, Inc.
LW Scientific ZIP IQ PCV Centrifuge, ZIC-24HD-75T3 Rev C Product Usage: used as a general purpose centrifuge to spin down blood in he...
Medical Devices·142 affected·Feb 6, 2019
High RiskFDA
Advanced Bionics, Llc
Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150.
Medical Devices·3 affected·Feb 6, 2019
High RiskFDA
Advanced Bionics, Llc
Na¿da CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140.
Medical Devices·1 affected·Feb 6, 2019
High RiskFDA
Lw Scientific, Inc.
LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-4RT3 Rev B Product Usage: used as a general purpose centrifuge to spin down blood in ...
Medical Devices·16 affected·Feb 6, 2019
High RiskFDA
Advanced Bionics, Llc
Na¿da CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150.
Medical Devices·4 affected·Feb 6, 2019
High RiskFDA
Moller Vital
Molift 2-Point sling bar, an accessory for Molift Mover 180/Air. Item nos. 1830001 1830002 1830002C 1830003
Medical Devices·427 affected·Feb 4, 2019
High RiskFDA
Encore Medical, Lp
EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096
Medical Devices·410 affected·Feb 4, 2019
High RiskFDA
Becton Dickinson & Company
3mL Luer-Lok Syringe, Catalog Number 309657, UDI 30382903096573
Medical Devices·460,800 affected·Feb 1, 2019
High RiskFDA
Zimmer Trabecular Metal Technology, Inc.
NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800436 ...
Medical Devices·26 affected·Feb 1, 2019