Category

Medical Devices Recalls

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

15,654 recalls
CriticalFDA
Inpeco S.a.
Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (AC...
Medical Devices·245 affected·Mar 10, 2023
CriticalFDA
Inpeco S.a.
Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP...
Medical Devices·245 affected·Mar 10, 2023
CriticalFDA
Inpeco S.a.
Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a360...
Medical Devices·245 affected·Mar 10, 2023
High RiskFDA
Medacta Usa Inc
MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device
Medical Devices·32 affected·Mar 8, 2023
High RiskFDA
Radiometer Medical Aps
AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage analytical devic...
Medical Devices·1,806 affected·Mar 8, 2023
High RiskFDA
Medacta Usa Inc
MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device
Medical Devices·44 affected·Mar 8, 2023
High RiskFDA
Biofire Diagnostics, Llc
FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
Medical Devices·900 affected·Mar 8, 2023
High RiskFDA
Medacta Usa Inc
MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device
Medical Devices·50 affected·Mar 8, 2023
High RiskFDA
Compass Health Brands (corporate Office)
REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle aches and/or pains, ...
Medical Devices·30 affected·Mar 7, 2023
High RiskFDA
Maquet Cardiovascular, Llc
VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000
Medical Devices·2,300 affected·Mar 6, 2023
High RiskFDA
Maquet Cardiovascular, Llc
VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH-3000-W
Medical Devices·235 affected·Mar 6, 2023
High RiskFDA
Philips North America Llc
EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359
Medical Devices·64 affected·Mar 6, 2023
High RiskFDA
Philips North America Llc
EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number: 863380
Medical Devices·1,421 affected·Mar 6, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile.
Medical Devices·162 affected·Mar 2, 2023
High RiskFDA
Stryker Corporation
SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200
Medical Devices·5,228 affected·Mar 2, 2023
High RiskFDA
Covidien, Lp
Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010
Medical Devices·770 affected·Mar 1, 2023
High RiskFDA
Atrium Medical Corporation
Express Mini 500 Dry Seal Chest Drain, Part Number 16400
Medical Devices·8,184 affected·Mar 1, 2023
High RiskFDA
Stryker Corporation
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK Catalog number: 5921-218-135NS
Medical Devices·1,730 affected·Mar 1, 2023
High RiskFDA
Shanghai United Imaging Healthcare Co., Ltd.
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number:...
Medical Devices·47 affected·Mar 1, 2023
High RiskFDA
Stryker Sustainability Solutions
Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single Bladder 30...
Medical Devices·127,894 affected·Mar 1, 2023
High RiskFDA
Covidien, Lp
Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915), CHROMIC GUT 4-0 75CM V2...
Medical Devices·36,204 affected·Mar 1, 2023
High RiskFDA
Omega Medical Imaging, Inc.
Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085
Medical Devices·52 affected·Feb 28, 2023
High RiskFDA
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Medical Devices·391 affected·Feb 28, 2023
High RiskFDA
Elekta Inc
Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Medical Devices·2,020 affected·Feb 28, 2023
High RiskFDA
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 099...
Medical Devices·391 affected·Feb 28, 2023
High RiskFDA
Tobii Dynavox Llc
Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities. Catalog #: 75...
Medical Devices·3,924 affected·Feb 24, 2023
High RiskFDA
Remote Diagnostic Technologies Ltd.
Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the...
Medical Devices·5,540 affected·Feb 23, 2023
High RiskFDA
Baxter Healthcare Corporation
Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
Medical Devices·16 affected·Feb 22, 2023
High RiskFDA
Entopsis , Inc.
PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF 5970025; e) 1000...
Medical Devices·363 affected·Feb 21, 2023
High RiskFDA
Preat Corp
Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
Medical Devices·26 affected·Feb 21, 2023
High RiskFDA
Entopsis , Inc.
PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples
Medical Devices·3 affected·Feb 21, 2023
High RiskFDA
Entopsis , Inc.
PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003; Improves the functionality of PCRopsis regents for...
Medical Devices·94 affected·Feb 21, 2023
High RiskFDA
Biosense Webster, Inc.
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile
Medical Devices·277 affected·Feb 21, 2023
High RiskFDA
Bio-rad Laboratories, Inc.
BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD
Medical Devices·225 affected·Feb 21, 2023
High RiskFDA
Philips Medical Systems Nederland B.v.
SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6
Medical Devices·1,461 affected·Feb 20, 2023
High RiskFDA
Mani, Inc. - Kiyohara Facility
Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3 pcs. trocar with...
Medical Devices·45 affected·Feb 20, 2023
High RiskFDA
Moberg Research, Inc.
Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoring system that collects, displays, an...
Medical Devices·89 affected·Feb 20, 2023
RecallFDA
Agilent Technologies Inc./us
Agilent Resolution ctDx FIRST Sample Collection Kit, 500032
Medical Devices·560 affected·Feb 17, 2023
High RiskFDA
Raysearch Laboratories Ab
Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9.1.0, 9.2.0, 10.0.0, 10.0.1, 10.0.2, 10.1.0, 10....
Medical Devices·10,770 affected·Feb 17, 2023
High RiskFDA
Medtronic Sofamor Danek Usa Inc
INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; for immobilization and stabilizatio...
Medical Devices·45 affected·Feb 16, 2023
High RiskFDA
Depuy Orthopaedics, Inc.
Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118
Medical Devices·7 affected·Feb 15, 2023
High RiskFDA
Depuy Orthopaedics, Inc.
Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312
Medical Devices·7 affected·Feb 15, 2023
High RiskFDA
Depuy Orthopaedics, Inc.
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212
Medical Devices·7 affected·Feb 15, 2023
High RiskFDA
Depuy Orthopaedics, Inc.
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226
Medical Devices·7 affected·Feb 15, 2023
High RiskFDA
Pro-dex Inc
KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a d...
Medical Devices·199 affected·Feb 14, 2023
High RiskFDA
Carefusion 303, Inc.
BD Pyxis Med ES Auxiliary (AUX), REF 343
Medical Devices·5,918 affected·Feb 14, 2023
High RiskFDA
Brainlab Ag
Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
Medical Devices·56 affected·Feb 14, 2023
High RiskFDA
Fenwal Inc
Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
Medical Devices·6,564 affected·Feb 14, 2023