Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 195 of 548
FDA Devices Moderate Dec 23, 2020
Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16
Galt Medical Corporation
FDA Devices Moderate Dec 23, 2020
Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180556, 180557,…
Biomet, Inc.
FDA Devices Moderate Dec 23, 2020
DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in occlusive peripheral vascular disease. Indications: For crossing…
Ra Medical Systems, Inc.
FDA Devices Moderate Dec 23, 2020
4.0/5.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009810, 110009821, 110009825, 110009852 - …
Biomet, Inc.
FDA Devices Moderate Dec 23, 2020
RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 103533, 103534, 103535 - Product Usage: Prosthesis, Hip, Semi-Constrained, M…
Biomet, Inc.
FDA Devices Moderate Dec 23, 2020
DePuy Synthes 11.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.018S
Synthes (USA) Products LLC
FDA Devices Moderate Dec 23, 2020
6.5/8.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009929, 110009934, 110009935, 110009936, …
Biomet, Inc.
FDA Devices Moderate Dec 16, 2020
MAC VU360, Electrocardiograph
GE Healthcare, LLC
FDA Devices Moderate Dec 16, 2020
Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures. P/N: 451A20…
Integra LifeSciences Corp.
FDA Devices Moderate Dec 16, 2020
Evolut (TM) PRO System. With the following model numbers: a. EVOLUTPRO-23, Labeled as: VLV EVOLUTPRO-23 PRO COMM 29L OUS, VLV EVOLUTPRO-23 BLUE…
Medtronic Heart Valves Division
FDA Devices Moderate Dec 16, 2020
MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Product Usage: The kit is intended for amino acid metabolic screening, confirm…
Chromsystems Instruments & Chemicals GmbH
FDA Devices Moderate Dec 16, 2020
PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage.
TissueTech, Inc.
FDA Devices Moderate Dec 16, 2020
Everest MI XT Tab Removal Tool (i.e. All-In-One Tab Removal Tool)-used to break the tab off the Everest XT screw by rocking the instrument back and f…
K2M, Inc
FDA Devices Moderate Dec 16, 2020
3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a t…
Chromsystems Instruments & Chemicals GmbH
FDA Devices Moderate Dec 16, 2020
CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector
Avanos Medical, Inc.
FDA Devices Moderate Dec 16, 2020
MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdomi…
Shimadzu Medical Systems
FDA Devices Moderate Dec 16, 2020
PROKERA, non-sterile - Product Usage: Biologic corneal bandage.
TissueTech, Inc.
FDA Devices Moderate Dec 16, 2020
Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan - Product Usage: The device is intende…
Shimadzu Medical Systems
FDA Devices Moderate Dec 16, 2020
PROKERA Slim, non-sterile - Product Usage: Biologic corneal bandage.
TissueTech, Inc.
FDA Devices Moderate Dec 16, 2020
Evolut (TM) PRO+ System. With the following model numbers: a. EVPROPLUS-23US, Labeled as VLV EVPROPLUS-23US COMM JPN, VLV EVPROPLUS-23 COMM US;…
Medtronic Heart Valves Division
FDA Devices Moderate Dec 16, 2020
ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiogra…
WELCH ALLYN, INC/MORTARA
FDA Devices Moderate Dec 16, 2020
MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - Product Usage: The kit is intended for amino acid metabolic screening, confi…
Chromsystems Instruments & Chemicals GmbH
FDA Devices Moderate Dec 16, 2020
VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a t…
LivaNova USA Inc
FDA Devices Moderate Dec 16, 2020
Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage: designed to provide fluoroscopic ima…
Shimadzu Medical Systems
FDA Devices Moderate Dec 16, 2020
Philips IntelliVue MP2 Patient Monitors (865040) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple phys…
Philips North America Llc
FDA Devices Moderate Dec 16, 2020
Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880
Randox Laboratories Ltd.
FDA Devices Moderate Dec 9, 2020
Olympus Ultrasound Endoscope, Model number: GF-UCT140P-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound …
Olympus Corporation of the Americas
FDA Devices Moderate Dec 9, 2020
CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-contro…
CME America, LLC
FDA Devices Moderate Dec 9, 2020
Olympus Ultrasound Endoscope, Model number: GF-UC160P-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human…
Olympus Corporation of the Americas
FDA Devices Moderate Dec 9, 2020
CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angiography System, Model numbers: Infinix-8000C and Infinix-8000…
Canon Medical System, USA, INC.
FDA Devices Moderate Dec 9, 2020
CME America T-Syringe Pump - T34L PCA - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-c…
CME America, LLC
FDA Devices Moderate Dec 9, 2020
Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the Alignment Tube ) provides counter rota…
K2M, Inc
FDA Devices Moderate Dec 9, 2020
Olympus Ultrasound Endoscope, Model number: GF-UE160-AL5 - Product Usage: used for endoscopic ultrasonic imaging of the gastrointestinal wall, bile a…
Olympus Corporation of the Americas
FDA Devices Moderate Dec 9, 2020
6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used as a test for patients to moni…
Chromsystems Instruments & Chemicals GmbH
FDA Devices Moderate Dec 9, 2020
B. Braun Introcan Safety IV Catheters, Product codes REF 4252500-01 4252519-01 4252535-01 4252560-01 4252586-01 4251890-01 4252535-01 4252586-…
Janus Trade Group
FDA Devices Moderate Dec 9, 2020
CME America T-Syringe Pump - Neofeed - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-co…
CME America, LLC
FDA Devices Moderate Dec 9, 2020
The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely used nucleic acid amplification technolo…
Biomeme, Inc.
FDA Devices Moderate Dec 9, 2020
REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 0.2 Micron Filter, 1.2 Micron Filter, 3 Clamps (Blue, Yellow, W…
ICU Medical, Inc.
FDA Devices Low Dec 9, 2020
Luminesse ML PMMA, 98x20mm, REF: 5336-B1 - Product Usage: used as a milling blank in the fabrication of provisional crowns and bridges. All blanks ar…
Talladium Inc
FDA Devices Moderate Dec 9, 2020
MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product Usage: indicated for continuous or periodic monitoring of glu…
Medtronic Inc.
FDA Devices Moderate Dec 9, 2020
MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is used as a test for patients to monitor their cortis…
Chromsystems Instruments & Chemicals GmbH
FDA Devices Moderate Dec 9, 2020
Olympus Ultrasound Endoscope, Model number :GF-UM20 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging…
Olympus Corporation of the Americas
FDA Devices Moderate Dec 9, 2020
Olympus Ultrasound Endoscope, Model number: GF-UMQ130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, l…
Olympus Corporation of the Americas
FDA Devices Moderate Dec 9, 2020
Olympus Ultrasound Endoscope, Model number: GF-UCT180 - Product Usage: used with an Olympus universal endoscopic ultrasound center or a diagnostic sy…
Olympus Corporation of the Americas
FDA Devices Moderate Dec 9, 2020
CME America T-Syringe Pump - Ameritus 1st Enteral Pump - Product Usage: infusion of medications or fluids requiring continuous or intermittent delive…
CME America, LLC
FDA Devices Moderate Dec 9, 2020
Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.
ROi CPS LLC
FDA Devices Moderate Dec 9, 2020
Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring supplemental oxygen Model Numbers: IRC5PO2V (U…
Invacare Corporation
FDA Devices Moderate Dec 9, 2020
MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placement in the …
Bausch & Lomb Surgical, Inc.
FDA Devices Moderate Dec 9, 2020
Olympus Ultrasound Endoscope, Model number: GF-UCT160-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human…
Olympus Corporation of the Americas
FDA Devices Moderate Dec 2, 2020
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 26L - is a single use, disposable cryoprobe that is desig…
MEDTRONIC ATS MEDICAL, INC.