PlainRecalls

Medical Devices Recalls

Medical device recalls including implants, diagnostic equipment, and surgical tools

27,372 recalls · Page 147 of 548

FDA Devices Moderate Jul 27, 2022

Hobbs Medical Polypectomy Snare, Catalog No. 7202

Hobbs Medical, Inc.

FDA Devices Moderate Jul 27, 2022

RayStation 9B SP1. For radiation treatment planning.

RAYSEARCH LABORATORIES AB

FDA Devices Moderate Jul 27, 2022

LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip

LumiraDx

FDA Devices Moderate Jul 27, 2022

BD Connecta" Plus3 White Blend OEM (sterile, bulk) Catalog No. 395214 (OUS)

Becton Dickinson & Company

FDA Devices Moderate Jul 27, 2022

SX-One MicroKnife

SONEX HEALTH LLC

CPSC Moderate Jul 21, 2022

Aqualung Recalls i330R SCUBA Diving Computers Due to Injury and Drowning Hazards

FDA Drug Moderate Jul 20, 2022

Teriparatide 226mcg/ml Injectable, 4 Pre-filled Syringes, 0.25 mL-Syringe, Refrigerate, Tailor Made Compounding

TMC Acquisition LLC dba Tailor Made Compounding

FDA Devices Moderate Jul 20, 2022

Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2817/32 Medium, W 16-2817/35 Large,…

Waldemar Link GmbH & Co. KG (Mfg Site)

FDA Devices Moderate Jul 20, 2022

Ventana HE 600 System, automated slide preparer, for use in laboratories.

Ventana Medical Systems Inc

FDA Devices Moderate Jul 20, 2022

Wright EVOLVE TRIAD Plate Cutter, REF 49510120

Wright Medical Technology, Inc.

FDA Devices Moderate Jul 20, 2022

Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)

Isopure Corp

FDA Devices Moderate Jul 20, 2022

DigitalDiagnost 4 High Performance. radiography and fluoroscopy system

Philips Medical Systems DMC GmbH

FDA Devices Moderate Jul 20, 2022

ProxiDiagnost N90. radiography and fluoroscopy system

Philips Medical Systems DMC GmbH

FDA Devices Moderate Jul 20, 2022

MiniMed 640G Insulin Pump (O.U.S. Version)

Medtronic MiniMed

FDA Devices Moderate Jul 20, 2022

MiniMed 740G Insulin Pump (O.U.S. Version)

Medtronic MiniMed

FDA Devices Moderate Jul 20, 2022

Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthopedic pros…

Waldemar Link GmbH & Co. KG (Mfg Site)

FDA Devices Moderate Jul 20, 2022

CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000

Zeltiq Aesthetics, Inc

FDA Devices Low Jul 20, 2022

Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)

Invacare Corporation

FDA Devices Moderate Jul 20, 2022

CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000

Zeltiq Aesthetics, Inc

FDA Devices Moderate Jul 20, 2022

Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM

Spectranetics Corporation

FDA Devices Moderate Jul 20, 2022

epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arteri…

Siemens Healthcare Diagnostics Inc

FDA Devices Moderate Jul 20, 2022

CoolCurve ZELTIQ Vaccum Applicator REF BRZ-AP1-062-000

Zeltiq Aesthetics, Inc

FDA Devices Moderate Jul 20, 2022

CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000

Zeltiq Aesthetics, Inc

FDA Devices Moderate Jul 20, 2022

Ivenix Infusion System (IIS)

Ivenix, Inc.

FDA Devices Moderate Jul 20, 2022

Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838

Cook Incorporated

FDA Devices Moderate Jul 20, 2022

NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failu…

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jul 20, 2022

MiniMed 670G Insulin Pump (U.S. and O.U.S. Version)

Medtronic MiniMed

FDA Devices Moderate Jul 20, 2022

ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605

SCIENCE & BIO MATERIALS

FDA Devices Moderate Jul 20, 2022

DigitalDiagnost C90 High Performance. radiography and fluoroscopy system

Philips Medical Systems DMC GmbH

FDA Devices Moderate Jul 20, 2022

Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF CATARACT SWAGEL WOOTTON EYE …

Alcon Research, LLC

FDA Devices Moderate Jul 20, 2022

AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Typ USA (G02040114-US), AquaBpl…

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jul 20, 2022

Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilati…

Breas Medical, Inc.

FDA Devices Moderate Jul 20, 2022

MiniMed 720G Insulin Pump (O.U.S. Version)

Medtronic MiniMed

FDA Devices Moderate Jul 20, 2022

CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000

Zeltiq Aesthetics, Inc

FDA Devices Moderate Jul 20, 2022

Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system

Draeger Medical Systems, Inc.

FDA Devices Low Jul 20, 2022

Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-21 …

Agilent Technologies, Inc.

FDA Devices Moderate Jul 20, 2022

NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failu…

Fresenius Medical Care Holdings, Inc.

FDA Devices Moderate Jul 20, 2022

DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system

Philips Medical Systems DMC GmbH

FDA Devices Moderate Jul 20, 2022

MiniMed 780G Insulin Pump (O.U.S. Version)

Medtronic MiniMed

FDA Devices Moderate Jul 20, 2022

MiniMed 770G Insulin Pump (U.S. and O.U.S. Version)

Medtronic MiniMed

FDA Devices Moderate Jul 20, 2022

Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis. Model Nos.: X-Small, Right 15-3815/11, Small, Right 15-3816/11, …

Waldemar Link GmbH & Co. KG (Mfg Site)

FDA Devices Moderate Jul 13, 2022

GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and data within a computer network or on a…

GE Healthcare, LLC

FDA Devices Moderate Jul 13, 2022

VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23

Luminex Corporation

FDA Devices Moderate Jul 13, 2022

Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600

Siemens Medical Solutions USA, Inc

FDA Devices Critical Jul 13, 2022

Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.

Covidien Llc

FDA Devices Critical Jul 13, 2022

Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.

Covidien Llc

FDA Devices Moderate Jul 13, 2022

RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens: (1) Outer carton labeled as…

Rayner Intraocular Lenses Ltd

FDA Devices Moderate Jul 13, 2022

Omnera 400A Digital Radiographic System

Arcoma AB

FDA Devices Critical Jul 13, 2022

Clean Catch Urine Kit NS 178489, AHMU58A

American Contract Systems, Inc.

FDA Devices Moderate Jul 13, 2022

Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in t…

Siemens Healthcare Diagnostics, Inc.