Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Baxter Healthcare Corporation
Sharesource Connectivity Platform for Use with the Amia Automated PD System
Medical Devices·1 affected·Jun 30, 2021
High RiskFDA
Aesculap Implant Systems Llc
RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.
Medical Devices·2 affected·Jun 30, 2021
High RiskFDA
Encore Medical, Lp
AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000, 3. Part # 520-1...
Medical Devices·0 affected·Jun 28, 2021
High RiskFDA
B. Braun Medical, Inc.
Infusomat Space Volumetric Pump Administration Set, Product Code 490100
Medical Devices·36,144 affected·Jun 25, 2021
High RiskFDA
Opti Medical Systems, Inc
OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
Medical Devices·3,552 affected·Jun 25, 2021
High RiskFDA
Cardioquip, Llc
CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices.
Medical Devices·1,380 affected·Jun 24, 2021
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
Medical Devices·2,058 affected·Jun 24, 2021
High RiskFDA
Bard Peripheral Vascular Inc
TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15 cm; TJC3513 Jamshidi" Bone Marrow B...
Medical Devices·3,961 affected·Jun 23, 2021
High RiskFDA
Bard Peripheral Vascular Inc
EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm
Medical Devices·560 affected·Jun 23, 2021
High RiskFDA
Beckman Coulter, Inc.
Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 - Kaluza C Single Perpetual License C10575 - Kaluza C S...
Medical Devices·1,085 affected·Jun 23, 2021
High RiskFDA
Biomerieux Sa
MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, ...
Medical Devices·248 affected·Jun 22, 2021
High RiskFDA
Accora Inc
Configura Advance Chair, Model Number: CHAIR-0-SC1-030; Advance Chair, 100mm Castors, Std Backrest, Manual; Serial Numbers: 10001-SC1-20...
Medical Devices·122 affected·Jun 21, 2021
High RiskFDA
Wom World Of Medicine Ag
Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000
Medical Devices·1,100 affected·Jun 18, 2021
High RiskFDA
Remel Inc
ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom
Medical Devices·327 affected·Jun 18, 2021
High RiskFDA
Medicalplastic S.r.l.
Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434
Medical Devices·581 affected·Jun 17, 2021
High RiskFDA
Baxter Healthcare Corporation
EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar.
Medical Devices·4,752 affected·Jun 15, 2021
High RiskFDA
Roi Cps Llc
Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer.
Medical Devices·688 affected·Jun 14, 2021
High RiskFDA
Ion Beam Applications S.a.
Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susce...
Medical Devices·27 affected·Jun 14, 2021
High RiskFDA
Roi Cps Llc
Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an infant heel warmer.
Medical Devices·976 affected·Jun 14, 2021
High RiskFDA
Arthrex, Inc.
Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
Medical Devices·3,985 affected·Jun 14, 2021
High RiskFDA
Roi Cps Llc
Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.
Medical Devices·608 affected·Jun 14, 2021
High RiskFDA
Ge Healthcare, Llc
Revolution EVO, Optima CT660, Optima CT680 CT Systems.
Medical Devices·3,665 affected·Jun 14, 2021
High RiskFDA
Abbott Laboratories
REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161866
Medical Devices·2,212 affected·Jun 10, 2021
CriticalFDA
Arjohuntleigh Polska Sp. Z.o.o.
Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX812A3J3AMAD0; and IndiGo modules (retr...
Medical Devices·367 affected·Jun 10, 2021
High RiskFDA
Merit Medical Systems, Inc.
basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional ...
Medical Devices·7,211 affected·Jun 10, 2021
CriticalFDA
Cardinal Health 200, Llc
Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T The infant heel warmer is activated at the point of ...
Medical Devices·926,425 affected·Jun 9, 2021
High RiskFDA
Philips North America Llc
728333 Spectral CT 7500 -Computed Tomography X-ray system
Medical Devices·1 affected·Jun 8, 2021
High RiskFDA
Philips North America Llc
728332 IQon Spectral CT-Computed Tomography X-ray system
Medical Devices·0 affected·Jun 8, 2021
High RiskFDA
Philips North America Llc
728327 Ingenuity CT Upgrades-Computed Tomography X-ray system
Medical Devices·3 affected·Jun 8, 2021
High RiskFDA
Philips North America Llc
728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
Medical Devices·3 affected·Jun 8, 2021
High RiskFDA
Pear Therapeutics, Inc.
reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
Medical Devices·3,370 affected·Jun 7, 2021
High RiskFDA
Pear Therapeutics, Inc.
reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
Medical Devices·812 affected·Jun 7, 2021
High RiskFDA
Ge Healthcare, Llc
SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio...
Medical Devices·100 affected·Jun 4, 2021
High RiskFDA
Ge Healthcare, Llc
SIGNA Artist, Nuclear Magnetic Resonance Imaging System
Medical Devices·562 affected·Jun 4, 2021
High RiskFDA
Ge Healthcare, Llc
SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Medical Devices·71 affected·Jun 4, 2021
High RiskFDA
Ge Healthcare, Llc
Discovery MR750w 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noi...
Medical Devices·585 affected·Jun 4, 2021
High RiskFDA
Ge Healthcare, Llc
1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System
Medical Devices·91 affected·Jun 4, 2021
High RiskFDA
Ge Healthcare, Llc
Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
Medical Devices·40 affected·Jun 4, 2021
CriticalFDA
Baxter Healthcare Corporation
Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.
Medical Devices·130,135 affected·Jun 4, 2021
CriticalFDA
Eight Medical International Bv
Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperthermic Perfusion System intended to ra...
Medical Devices·22 affected·Jun 4, 2021
High RiskFDA
Axonics Modulation Technologies, Inc.
BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476
Medical Devices·2,702 affected·Jun 3, 2021
CriticalFDA
Boston Scientific Corporation
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
Medical Devices·3,634 affected·Jun 3, 2021
CriticalFDA
Boston Scientific Corporation
INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
Medical Devices·1,707 affected·Jun 3, 2021
High RiskFDA
Biomet, Inc.
Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM Item Number: 11-301301
Medical Devices·0 affected·Jun 2, 2021
High RiskFDA
Biomet, Inc.
Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-301300
Medical Devices·88 affected·Jun 2, 2021
High RiskFDA
Biomet, Inc.
Arcos Modular Revision Hip System Standard Cone Prox Body, Size C, 80 MM Item Number: 11-301343
Medical Devices·0 affected·Jun 2, 2021
High RiskFDA
Biomet, Inc.
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 60 MM Item Number: 11-301314
Medical Devices·10 affected·Jun 2, 2021
High RiskFDA
Biomet, Inc.
Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 70 MM Item Number: 11-301321
Medical Devices·11 affected·Jun 2, 2021