Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Innovative Tomography Product Gmbh
Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. BIM 18/10, Length 1...
Medical Devices·0 affected·Apr 21, 2021
High RiskFDA
Innovative Tomography Product Gmbh
Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIM 22/05, Length ...
Medical Devices·0 affected·Apr 21, 2021
High RiskFDA
Medivators, Inc.
Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidne...
Medical Devices·1,381 affected·Apr 20, 2021
High RiskFDA
Elekta, Inc.
Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud
Medical Devices·40 affected·Apr 20, 2021
High RiskFDA
Change Healthcare Canada Company
Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM a...
Medical Devices·33 affected·Apr 19, 2021
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614), Discovery IGS 7...
Medical Devices·139 affected·Apr 19, 2021
High RiskFDA
Ehob, Inc.
Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of pressure injuries or bed ...
Medical Devices·70 affected·Apr 19, 2021
High RiskFDA
Hardy Diagnostics
Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.
Medical Devices·69 affected·Apr 16, 2021
High RiskFDA
Terumo Cardiovascular Systems Corporation
The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for...
Medical Devices·995 affected·Apr 16, 2021
High RiskFDA
Terumo Cardiovascular Systems Corporation
The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an ext...
Medical Devices·1,176 affected·Apr 16, 2021
High RiskFDA
Biofire Diagnostics, Llc
FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
Medical Devices·9 affected·Apr 16, 2021
High RiskFDA
Vygon U.s.a.
Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.
Medical Devices·8,320 affected·Apr 15, 2021
High RiskFDA
Flower Orthopedics Corporation
T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T2...
Medical Devices·47 affected·Apr 15, 2021
High RiskFDA
Boston Scientific Corporation
UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usage: intended for use as a bridging material for sacrocolposu...
Medical Devices·8,524 affected·Apr 15, 2021
High RiskFDA
Haag-streit Usa Inc
Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.
Medical Devices·0 affected·Apr 15, 2021
High RiskFDA
Boston Scientific Corporation
Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and...
Medical Devices·4,549 affected·Apr 15, 2021
High RiskFDA
Beckman Coulter Inc.
Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.10 mL, R1e
Medical Devices·1,034 affected·Apr 14, 2021
High RiskFDA
Radiometer Medical Aps
E3800 PC Units (spare parts)
Medical Devices·965 affected·Apr 14, 2021
High RiskFDA
Radiometer Medical Aps
Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.
Medical Devices·3,346 affected·Apr 14, 2021
High RiskFDA
Philips North America Llc
BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306
Medical Devices·2 affected·Apr 13, 2021
High RiskFDA
Dj Orthopedics De Mexico S.a. De C.v.
DONJOY REF:11-0472-9 ULTRASLING PRO ER/IR 30, UNIVERSAL, Rx ONLY, UDI: (01)00190446683674 - Product Usage: intended for medical purposes...
Medical Devices·0 affected·Apr 12, 2021
CriticalFDA
Avid Medical, Inc.
FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020.
Medical Devices·720 affected·Apr 9, 2021
CriticalFDA
Avid Medical, Inc.
DIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03.
Medical Devices·560 affected·Apr 9, 2021
CriticalFDA
Medical Action Industries, Inc. 306
Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B
Medical Devices·10 affected·Apr 9, 2021
CriticalFDA
Medical Action Industries, Inc. 306
Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420
Medical Devices·30 affected·Apr 9, 2021
CriticalFDA
Avid Medical, Inc.
ADULT CHEST TUBE TRAY. Medical convenience kit, Avid Medical Part Number: LAKC001-04
Medical Devices·130 affected·Apr 9, 2021
CriticalFDA
Medical Action Industries, Inc. 306
Kit: Blood Culture. MAI Kit Part Number: 80315D
Medical Devices·205 affected·Apr 9, 2021
High RiskFDA
Meridian Bioscience Inc
Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) qualitative t...
Medical Devices·376 affected·Apr 8, 2021
High RiskFDA
Spes Medica
Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring.
Medical Devices·3 affected·Apr 8, 2021
High RiskFDA
Raysearch Laboratories Ab
RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some servic...
Medical Devices·0 affected·Apr 7, 2021
High RiskFDA
Clinical Laserthermia Systems Ab
Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device ...
Medical Devices·40 affected·Apr 1, 2021
High RiskFDA
Merits Holdings Co. Dba Merits Health Products, Inc.
Power Wheelchair
Medical Devices·3,054 affected·Apr 1, 2021
High RiskFDA
Clinical Laserthermia Systems Ab
Tranberg MR Cannula, REF: 4013-05, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the i...
Medical Devices·40 affected·Apr 1, 2021
High RiskFDA
Clinical Laserthermia Systems Ab
Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, Rx Only, Sterile EO - Product Usage: used with the...
Medical Devices·90 affected·Apr 1, 2021
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two ...
Medical Devices·321 affected·Apr 1, 2021
High RiskFDA
Merits Holdings Co. Dba Merits Health Products, Inc.
Scooter
Medical Devices·189 affected·Apr 1, 2021
High RiskFDA
Smiths Medical Asd Inc.
Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 122 cm, REF 607281. component of extravascular blood-pressur...
Medical Devices·11,340 affected·Mar 31, 2021
High RiskFDA
Smiths Medical Asd Inc.
Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR b. 1050 STOPCOCK LEFT ROTATOR, OFF HANDLE, Mo...
Medical Devices·3,825 affected·Mar 31, 2021
High RiskFDA
Smiths Medical Asd Inc.
LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitoring and blood sampling.
Medical Devices·200 affected·Mar 31, 2021
High RiskFDA
Smiths Medical Asd Inc.
Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1232MR b. 250 3 GANG MANIFOLD ROTATOR, OFF HAN...
Medical Devices·1,380 affected·Mar 31, 2021
High RiskFDA
Welch Allyn Inc Mortara
Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5...
Medical Devices·213 affected·Mar 31, 2021
High RiskFDA
Welch Allyn Inc Mortara
AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult ...
Medical Devices·746 affected·Mar 31, 2021
High RiskFDA
Smiths Medical Asd Inc.
Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids. Stopcocks and manifolds are used to control the direction ...
Medical Devices·400 affected·Mar 31, 2021
High RiskFDA
Soft Computer Consultants, Inc.
SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecul...
Medical Devices·1 affected·Mar 31, 2021
High RiskFDA
Smiths Medical Asd Inc.
Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascular blood-pressure Transducer.
Medical Devices·500 affected·Mar 31, 2021
High RiskFDA
Smiths Medical Asd Inc.
HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX496HP b. WITH FEMALE LUER LOCK, Model Number MX497HP. comp...
Medical Devices·8,150 affected·Mar 31, 2021
High RiskFDA
Smiths Medical Asd Inc.
HIGH PRESSURE TUBING, 72IN, Model Number MX152114 (Component). Stopcocks and manifolds are used to control the direction of IV fluid flow.
Medical Devices·275 affected·Mar 31, 2021
High RiskFDA
Greiner Bio-one North America, Inc.
VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged - Product Usage:...
Medical Devices·1,049,700 affected·Mar 29, 2021