Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Karl Storz Endoscopy
Flexible Intubation Fiberscope, Part: 11302BD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examinatio...
Medical Devices·650 affected·Jul 27, 2020
High RiskFDA
Karl Storz Endoscopy
Flexible Intubation Video Endoscope, Part: 11303BNX, with Instruction Manual: Z20827US - Product Usage: are intended to be used for exami...
Medical Devices·380 affected·Jul 27, 2020
High RiskFDA
Nuvasive Specialized Orthopedics Inc
NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur Trochanter 10 Degree Bend Component of the orthopedic Pr...
Medical Devices·41 affected·Jul 24, 2020
High RiskFDA
Intrinsic Therapeutics, Inc.
Barricaid Annual Closure Device (ACD) BAR-A8-8MM - Product Usage: The Barricaid¿ ACD is indicated for reducing the incidence of reherniat...
Medical Devices·110 affected·Jul 24, 2020
High RiskFDA
Ra Medical Systems, Inc.
DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vas...
Medical Devices·54 affected·Jul 24, 2020
High RiskFDA
Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15¿
Medical Devices·0 affected·Jul 22, 2020
High RiskFDA
Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8¿
Medical Devices·0 affected·Jul 22, 2020
High RiskFDA
Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15¿
Medical Devices·0 affected·Jul 22, 2020
High RiskFDA
Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8¿
Medical Devices·0 affected·Jul 22, 2020
High RiskFDA
Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8¿
Medical Devices·0 affected·Jul 22, 2020
High RiskFDA
Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15¿
Medical Devices·0 affected·Jul 22, 2020
High RiskFDA
Smith & Nephew Orthopaedics Ag
POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size ...
Medical Devices·528 affected·Jul 22, 2020
High RiskFDA
Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 15¿
Medical Devices·0 affected·Jul 22, 2020
High RiskFDA
Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15¿
Medical Devices·0 affected·Jul 22, 2020
High RiskFDA
Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8¿
Medical Devices·0 affected·Jul 22, 2020
High RiskFDA
Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿
Medical Devices·0 affected·Jul 22, 2020
High RiskFDA
Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15¿
Medical Devices·0 affected·Jul 22, 2020
High RiskFDA
Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 8¿
Medical Devices·0 affected·Jul 22, 2020
High RiskFDA
Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ (sterile)
Medical Devices·0 affected·Jul 22, 2020
High RiskFDA
Beyond White Spa Llc D.b.a. Ezywipe Of Amercia
Ezycare Face Mask, Disposable Non Medical Face Masks - Product Usage: marketed under face mask umbrella EUA as source control.
Medical Devices·18,500,000 affected·Jul 21, 2020
High RiskFDA
Ortho Clinical Diagnostics
VITROS XT7600 Integrated System, Product code 6844461
Medical Devices·0 affected·Jul 20, 2020
High RiskFDA
Ortho Clinical Diagnostics
VITROS XT3400 Chemistry System, Product code 6844458
Medical Devices·0 affected·Jul 20, 2020
High RiskFDA
Ion Beam Applications S.a.
Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce ...
Medical Devices·2 affected·Jul 17, 2020
High RiskFDA
Diasorin Inc.
Parvovirus B19 IgG EIA kit Part No. V519IGUS
Medical Devices·615 affected·Jul 17, 2020
High RiskFDA
Medtronic Neuromodulation
Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
Medical Devices·2,408 affected·Jul 17, 2020
High RiskFDA
Brainlab Ag
BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655
Medical Devices·9 affected·Jul 16, 2020
High RiskFDA
Brainlab Ag
BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011
Medical Devices·18 affected·Jul 16, 2020
High RiskFDA
Stimwave Technologies Inc
StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provid...
Medical Devices·6 affected·Jul 15, 2020
High RiskFDA
Stimwave Technologies Inc
StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product Usage: is used for peripheral neural stimulation to provide...
Medical Devices·1,550 affected·Jul 15, 2020
High RiskFDA
Hager & Meisinger Gmbh
SINGLES Carbide US-No. FG556; UDI +E0HM26000313140091; STERILE R; Size 009, Length 3.8; 2025-03-18 - Product Usage: Cutting of hard struc...
Medical Devices·144 affected·Jul 15, 2020
High RiskFDA
Stimwave Technologies Inc
StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and 2. FR4A-RCV-A0 EU - Product Usage: is used for peripheral n...
Medical Devices·13 affected·Jul 15, 2020
High RiskFDA
Stimwave Technologies Inc
StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neur...
Medical Devices·2,444 affected·Jul 15, 2020
High RiskFDA
Neurologica Corporation
OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Product Usage: is inte...
Medical Devices·35 affected·Jul 15, 2020
High RiskFDA
Stimwave Technologies Inc
StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - Product Usage: is used for peripheral neura...
Medical Devices·1,424 affected·Jul 15, 2020
High RiskFDA
Medtronic Inc.
The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.
Medical Devices·3,588 affected·Jul 15, 2020
High RiskFDA
Stimwave Technologies Inc
StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide...
Medical Devices·2,197 affected·Jul 15, 2020
High RiskFDA
Inpeco S.a.
Accelerator a3600 Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Autom...
Medical Devices·136 affected·Jul 14, 2020
High RiskFDA
Olympus Corporation Of The Americas
Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662
Medical Devices·21 affected·Jul 14, 2020
High RiskFDA
Inpeco S.a.
Aptio Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a ...
Medical Devices·104 affected·Jul 14, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 Cios Alpha and Cios Spin...
Medical Devices·282 affected·Jul 14, 2020
High RiskFDA
Thomas Scientific
Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.
Medical Devices·115,800 affected·Jul 14, 2020
High RiskFDA
Mako Surgical Corporation
Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
Medical Devices·12 affected·Jul 9, 2020
High RiskFDA
Flower Orthopedics Corporation
Calcaneus Plate, Extensile, Medium, Left, Catalog Number CPF 102 - Product Usage: intended to be used for internal fixation of fractures ...
Medical Devices·25 affected·Jul 8, 2020
High RiskFDA
New Wave Endo-surgical, Corp.
M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
Medical Devices·295 affected·Jul 8, 2020
High RiskFDA
Flower Orthopedics Corporation
Calcaneus Plate, Extensile, Large, Right, Catalog Number CPF 203 - Product Usage: intended to be used for internal fixation of fractures ...
Medical Devices·25 affected·Jul 8, 2020
High RiskFDA
Flower Orthopedics Corporation
Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - Product Usage: intended to be used for internal fixation of fractures ...
Medical Devices·25 affected·Jul 8, 2020
High RiskFDA
Teleflex Medical Inc
Rusch Greenlite Product Code: 004550002 GTIN: 14026704663061 (each) - Product Usage: The laryngoscope is a device intended to allow di...
Medical Devices·75,320 affected·Jul 6, 2020
High RiskFDA
Gentueri Inc
Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
Medical Devices·13,975 affected·Jul 6, 2020