Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 105 of 548
FDA Devices Moderate Sep 6, 2023
LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000 model numbe…
Cardiac Assist, Inc
FDA Devices Critical Sep 6, 2023
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33…
Datascope Corp.
FDA Devices Moderate Sep 6, 2023
Oculus Pentacam AXL , Ref 70100, CE 0123
Oculus Optikgeraete GMBH
FDA Devices Moderate Sep 6, 2023
Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma (lithium …
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Sep 6, 2023
Olympus Bronchovideoscope, Models BF-3C160.
Olympus Corporation of the Americas
FDA Devices Moderate Sep 6, 2023
Olympus Tracheal Intubation Fiberscope, Models LF-P & LF-V.
Olympus Corporation of the Americas
FDA Devices Moderate Sep 6, 2023
Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and pl…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Sep 6, 2023
Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human serum and plasma (lithium hepa…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Sep 6, 2023
Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human serum and plasma (lithium hepari…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Sep 6, 2023
Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF-TE2, BF-XT160.
Olympus Corporation of the Americas
FDA Devices Moderate Sep 6, 2023
Olympus Bronchovideoscope, Models BF-MP160F, BF-XP160F, BF-XP60.
Olympus Corporation of the Americas
FDA Devices Critical Sep 6, 2023
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33…
Datascope Corp.
FDA Devices Moderate Sep 6, 2023
GS70H Salus Surgical Table, Product Code 18-071-70
Skytron, LLC
FDA Devices Moderate Sep 6, 2023
Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination of total protein in human serum and plasma (lithium heparin) …
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Sep 6, 2023
Olympus Bronchovideoscope, Models BF-P190 & BF-XP190.
Olympus Corporation of the Americas
FDA Devices Moderate Sep 6, 2023
Olympus Airway Mobilescope, Models MAF-DM2, MAF-GM2, & MAF-TM2.
Olympus Corporation of the Americas
FDA Devices Moderate Sep 6, 2023
Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F.
Olympus Corporation of the Americas
FDA Devices Moderate Sep 6, 2023
PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
Edwards Lifesciences, LLC
FDA Devices Moderate Sep 6, 2023
Visera Hysterovideoscope Olympus HYF Type V
Olympus Corporation of the Americas
FDA Devices Moderate Sep 6, 2023
Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis implant during a total knee arthro…
Waldemar Link GmbH & Co. KG (Mfg Site)
FDA Devices Moderate Sep 6, 2023
Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium hepar…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Critical Sep 6, 2023
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Datascope Corp.
FDA Devices Critical Sep 6, 2023
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Datascope Corp.
FDA Devices Moderate Sep 6, 2023
SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and recording the nu…
Stryker Corporation
FDA Devices Moderate Sep 6, 2023
Olympus Tracheal Intubation Fiberscope, Models LF-DP, LF-GP, & LF-TP.
Olympus Corporation of the Americas
FDA Devices Moderate Sep 6, 2023
Olympus Bronchovideoscope, Model BF-Q180-AC
Olympus Corporation of the Americas
FDA Devices Moderate Sep 6, 2023
Olympus Bronchovideoscope, Models BF-MP190F.
Olympus Corporation of the Americas
FDA Devices Moderate Sep 6, 2023
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
Olympus Corporation of the Americas
FDA Devices Moderate Sep 6, 2023
LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, Transcend LIF and Battalion LL…
Alphatec Spine, Inc.
FDA Devices Moderate Sep 6, 2023
Oculus Myopia Master , Ref 68100, CE 0123
Oculus Optikgeraete GMBH
FDA Devices Moderate Sep 6, 2023
Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Sep 6, 2023
Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in human serum and plasma (lithium hepari…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Sep 6, 2023
PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective measurement of the refractive error of the eye. MODEL NUMBER: …
Reichert, Inc.
FDA Devices Moderate Sep 6, 2023
Atellica CH Triglycerides_2: in vitro diagnostic use in the quantitative determination of triglycerides in human serum and plasma (lithium heparin, s…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Sep 6, 2023
The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ or non-reversed bypass proced…
LeMaitre Vascular, Inc.
FDA Devices Moderate Sep 6, 2023
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Datascope Corp.
FDA Drug Moderate Aug 30, 2023
Helix Pain Relieving Cream (Menthol 7.4%), packaged in a) 5 gm pouch (NDC 30775-051-01), b) 3 fl. oz. roll-on (NDC 30775-051-03), c) 4 fl. oz. tubes …
Parker Laboratories, Inc.
FDA Drug Moderate Aug 30, 2023
Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and potassium iodide 0.100gm, 8mL Single Use Vials, Rx Only, Manufactured for Co…
Ecometics, Inc.
FDA Drug Moderate Aug 30, 2023
AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6065-0, Ref 60…
Ecometics, Inc.
FDA Drug Moderate Aug 30, 2023
Protex Foaming Hand Sanitizer (Benzalkonium Chloride 0.13%), packaged in a) 2 fl oz/60 mL Pump bottles (NDC 30775-040-02) and b)18 fl. oz./550 ml Pum…
Parker Laboratories, Inc.
FDA Devices Moderate Aug 30, 2023
Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, CRP, Ferrit…
Randox Laboratories Ltd.
FDA Devices Moderate Aug 30, 2023
The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE, ULTRASONIC COLONOVIDEO…
Olympus Corporation of the Americas
FDA Devices Moderate Aug 30, 2023
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the quantitative determination of t…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Aug 30, 2023
EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator
Boston Scientific Corporation
FDA Devices Moderate Aug 30, 2023
The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs. or…
Medtronic Navigation, Inc.-Littleton
FDA Devices Moderate Aug 30, 2023
IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion de…
Medicrea International
FDA Devices Moderate Aug 30, 2023
IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, g) B20240207, h) B20…
Medicrea International
FDA Devices Moderate Aug 30, 2023
BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only
BioFire Diagnostics, LLC
FDA Devices Moderate Aug 30, 2023
IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B20181753, f) B20181763, g) B20181773, h) B2018…
Medicrea International
FDA Devices Critical Aug 30, 2023
Carina Sub-Acute Care Ventilator
Draeger Medical, Inc.