Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Medline Industries Inc
Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute spec...
Medical Devices·24 affected·Mar 15, 2021
High RiskFDA
Liebel-flarsheim Company Llc
HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
Medical Devices·17 affected·Mar 11, 2021
High RiskFDA
Krishe Inc
Dasky Disposable Sampling Tube, REF VSM02, Contents: Transport Media - 50, Nasal swab - 50, Package Insert - 1, IVD, CE
Medical Devices·441,500 affected·Mar 11, 2021
High RiskFDA
Stryker Spine
Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL Inserter (580220100), TL Draw Rod (5802201...
Medical Devices·169 affected·Mar 11, 2021
High RiskFDA
Krishe Inc
Dasky Disposable Sampling Tube, REF VSM03, Contents: Sterile 0.85% Saline - 50, Nasal Swab - 50 , Package Insert - 1, IVD, CE
Medical Devices·18,000 affected·Mar 11, 2021
High RiskFDA
Krishe Inc
Dasky Disposable Sampling Tube, REF VSM04 (Saliva Collection Kit + VTM), 10 pcs, IVD, Sterile R
Medical Devices·10,000 affected·Mar 11, 2021
High RiskFDA
Remel Inc
Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in ...
Medical Devices·19 affected·Mar 10, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System generate Xray images from the whole body including the skull...
Medical Devices·12 affected·Mar 10, 2021
High RiskFDA
Arrow International Inc
Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US) Product Code: 9464-...
Medical Devices·3,756 affected·Mar 8, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·674 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·8 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·15 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·132 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·33 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·0 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·195 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·185 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·1 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·27 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·43 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·1,452 affected·Mar 5, 2021
High RiskFDA
Roi Cps Llc
Regard, Item Number 830067009, custom cardiovascular procedure kit
Medical Devices·16 affected·Mar 4, 2021
CriticalFDA
Covidien, Lp
Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Item Code: SIGSDL45CTVT
Medical Devices·5,928 affected·Mar 4, 2021
High RiskFDA
Arjohuntleigh Magog, Inc.
Maxi Sky 1000 (Arjo) and V10 (BHM) Bariatric Ceiling Rail - Mounted Lift with measuring function
Medical Devices·62 affected·Mar 4, 2021
CriticalFDA
Covidien, Lp
Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/Thin 8 mm - Short Item Code:SIGSDS30CTVT
Medical Devices·15,298 affected·Mar 4, 2021
High RiskFDA
P-chip Corporation
p-Chip Wand Reader
Medical Devices·329 affected·Mar 3, 2021
CriticalFDA
Carefusion 303, Inc.
BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Part...
Medical Devices·160,300 affected·Mar 3, 2021
CriticalFDA
Medtronic Perfusion Systems
Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardio...
Medical Devices·387 affected·Mar 3, 2021
High RiskFDA
Raysearch Laboratories Ab
RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering c...
Medical Devices·1 affected·Mar 3, 2021
High RiskFDA
Terumo Cardiovascular Systems Corporation
Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm w...
Medical Devices·12 affected·Mar 2, 2021
High RiskFDA
Cellex
Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
Medical Devices·44,821 affected·Mar 1, 2021
High RiskFDA
Abiomed, Inc.
Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems ...
Medical Devices·4,463 affected·Mar 1, 2021
High RiskFDA
James Leckey Design Ltd
MyWay Walker Chassis - Product Usage: is intended for use by children already using a supportive walking device.
Medical Devices·2,719 affected·Mar 1, 2021
High RiskFDA
Accuray Incorporated
CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and precision radiotherapy for...
Medical Devices·243 affected·Feb 26, 2021
CriticalFDA
Step-har Medical Llc
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
Medical Devices·2 affected·Feb 26, 2021
CriticalFDA
Heartware, Inc.
Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN, 1401IT, 1401JP, ...
Medical Devices·56,018 affected·Feb 26, 2021
CriticalFDA
Heartware, Inc.
Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE
Medical Devices·114,133 affected·Feb 26, 2021
CriticalFDA
Heartware, Inc.
Medtronic HVAD Monitor Data Cable, Product Number: 1575
Medical Devices·1,337 affected·Feb 26, 2021
High RiskFDA
Covidien Llc
CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring ...
Medical Devices·62,551 affected·Feb 26, 2021
High RiskFDA
Covidien Llc
BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring...
Medical Devices·62,551 affected·Feb 26, 2021
CriticalFDA
Heartware, Inc.
Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT, 1425US, 1430AR,...
Medical Devices·17,992 affected·Feb 26, 2021
CriticalFDA
Heartware, Inc.
Medtronic HVAD Alarm Adapter, Product Number: 1450
Medical Devices·418 affected·Feb 26, 2021
CriticalFDA
Heartware, Inc.
Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511BR, 1511CA, 1511CH, 1511DE, 1511GB, 15...
Medical Devices·3,283 affected·Feb 26, 2021
High RiskFDA
Cardinal Health 200, Llc
In-View Clear Leggings Sterile
Medical Devices·28,417 affected·Feb 25, 2021
High RiskFDA
Fenwal Inc
Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.
Medical Devices·2,466 affected·Feb 25, 2021
High RiskFDA
Dutch Ophthalmic Usa, Inc.
Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, pr...
Medical Devices·12 affected·Feb 25, 2021
CriticalFDA
Biomedical Equipment Service Co (bmes)
Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part ...
Medical Devices·718 affected·Feb 25, 2021
High RiskFDA
Fenwal Inc
Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mononuclear cells.
Medical Devices·4,488 affected·Feb 25, 2021