Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 148 of 548
FDA Devices Critical Jul 13, 2022
Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
American Contract Systems, Inc.
FDA Devices Moderate Jul 13, 2022
Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in th…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Critical Jul 13, 2022
Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Covidien Llc
FDA Devices Moderate Jul 13, 2022
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
Chromsystems Instruments & Chemicals GmbH
FDA Devices Critical Jul 13, 2022
Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Covidien Llc
FDA Devices Moderate Jul 13, 2022
Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Jul 13, 2022
Omnera 400T Digital Radiographic System
Arcoma AB
FDA Devices Moderate Jul 13, 2022
CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpC…
Menarini Silicon Biosystems
FDA Devices Critical Jul 13, 2022
Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Covidien Llc
FDA Devices Moderate Jul 13, 2022
EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients…
DePuy Spine, Inc.
FDA Devices Moderate Jul 13, 2022
EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.
Covidien, LP
FDA Devices Moderate Jul 13, 2022
Verigene CDF Nucleic Acid Test, Part No. 30-002-22
Luminex Corporation
FDA Devices Moderate Jul 13, 2022
OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.
Ossur Americas
FDA Devices Moderate Jul 6, 2022
System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW
Canon Medical System, USA, INC.
FDA Devices Moderate Jul 6, 2022
ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.)
FDA Devices Moderate Jul 6, 2022
Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019
GE Healthcare, LLC
FDA Devices Moderate Jul 6, 2022
Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.
Wright Medical Technology, Inc.
FDA Devices Moderate Jul 6, 2022
HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoined Suction and Irrigation Tubing, Catalog Numbe…
Davol, Inc.
FDA Devices Moderate Jul 6, 2022
Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Jul 6, 2022
VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP ARD568811911 VLT600SF AIM STP ARD568811961 VLT600DF AIM STP…
Getinge Usa Sales Inc
FDA Devices Moderate Jul 6, 2022
NaviCare Nurse Call/Voalte Nurse Call
Baxter Healthcare Corporation
FDA Devices Moderate Jul 6, 2022
Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Jul 6, 2022
TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
Haemonetics Corporation
FDA Devices Moderate Jul 6, 2022
regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.
ROi CPS LLC
FDA Devices Moderate Jul 6, 2022
DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the distal r…
CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD.
FDA Devices Moderate Jul 6, 2022
HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle only, with Cojoined Suction and Irrigation Tubing, Catalog …
Davol, Inc.
FDA Devices Low Jul 6, 2022
Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
Volcano Corp
FDA Devices Moderate Jul 6, 2022
Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A
Skytron, Div. The KMW Group, Inc
FDA Devices Moderate Jul 6, 2022
Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.
K2M, Inc.
FDA Devices Moderate Jul 6, 2022
QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3 QMS TACROLIMUS CAL B 10015567-3 QMS TACROLIMUS CAL C 1001…
Microgenics Corporation
FDA Devices Moderate Jul 6, 2022
#1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LED
Baxter Healthcare Corporation
FDA Devices Moderate Jul 6, 2022
Arrow Three-Lumen CVC
ARROW INTERNATIONAL Inc.
FDA Devices Moderate Jun 29, 2022
EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model…
Olympus Corporation of the Americas
FDA Devices Moderate Jun 29, 2022
BVI Wet -Field Eraser, 18GA Blunt Tip, 45Deg.-Intended to remove tissue and control bleeding by the use of high frequency electrical current Part N…
Beaver Visitec International, Inc.
FDA Devices Moderate Jun 29, 2022
Colonovideoscope Model CF-H180AL
Olympus Corporation of the Americas
FDA Devices Moderate Jun 29, 2022
REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,
Bard Peripheral Vascular Inc
FDA Devices Critical Jun 29, 2022
HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
Medtronic Inc
FDA Devices Critical Jun 29, 2022
Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Numb…
Getinge Usa Sales Inc
FDA Devices Moderate Jun 29, 2022
INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour surface and non-velour inner surfa…
Maquet Cardiovascular, LLC
FDA Devices Critical Jun 29, 2022
Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306, 3500-402, 3500-4…
Smiths Medical ASD Inc.
FDA Devices Critical Jun 29, 2022
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-2…
Smiths Medical ASD Inc.
FDA Devices Moderate Jun 29, 2022
Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A
New Standard Device Inc
FDA Devices Moderate Jun 22, 2022
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
Tandem Diabetes Care Inc
FDA Devices Critical Jun 22, 2022
Drager SafeStar 55, Catalog No. MP01790
Draeger Medical, Inc.
FDA Devices Moderate Jun 22, 2022
AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
Micro Therapeutics, Inc.
FDA Devices Moderate Jun 22, 2022
Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
Volcano Corp
FDA Devices Moderate Jun 22, 2022
Crome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR: DVPC3D1, DVPC3D4; b) Crome DR: DDPC3D1, D…
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA Devices Moderate Jun 22, 2022
Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R
Olympus Corporation of the Americas
FDA Devices Moderate Jun 22, 2022
Olympus URETERO-RENO FIBERSCOPE Model: URF-P6
Olympus Corporation of the Americas
FDA Drug Moderate Jun 15, 2022
E-Z-Gas II, Effervescent Granules, Net Weight: 4 g, 50 packets per box, MFG: Bracco Diagnostics Inc., NDC 0270-9020-01 (discontinued), NDC 10361-793-…
Mckesson Medical-Surgical Inc. Corporate Office