Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 191 of 548
FDA Devices Moderate Jan 20, 2021
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Siemens Medical Solutions USA, Inc
FDA Devices Moderate Jan 20, 2021
Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functiona…
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Jan 20, 2021
Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument - Product Usage: intended to keep instruments moist during transportat…
Steris Corporation
FDA Devices Moderate Jan 20, 2021
NaturaLyte Liquid Acid concentrate drums, Model Number 13-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarb…
Fresenius Medical Care Holdings, Inc.
FDA Devices Critical Jan 20, 2021
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVSUS250, GTIN 08714729960911, M…
Boston Scientific Corporation
FDA Devices Moderate Jan 20, 2021
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…
Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Jan 20, 2021
NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarb…
Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Jan 20, 2021
VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP) concentration in serum and plasma u…
Ortho Clinical Diagnostics Inc
FDA Devices Moderate Jan 20, 2021
AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1 X ! Plate, IgM Sample DIL 1 x 100 mL, ENZ CONJ CONC 1 x 1.5 m…
Ansh Labs, LLC
FDA Devices Moderate Jan 20, 2021
CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes Software U…
Medtronic Inc.
FDA Devices Moderate Jan 20, 2021
GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope …
GE Healthcare, LLC
FDA Devices Moderate Jan 20, 2021
All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Affiniti 50, A…
Philips Ultrasound Inc
FDA Devices Moderate Jan 20, 2021
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…
Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Jan 20, 2021
Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number H3910AG) - Product Usage: intended for gen…
GE Healthcare, LLC
FDA Devices Moderate Jan 20, 2021
Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066001 - Product Usage: inten…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Jan 20, 2021
Naturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…
Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Jan 20, 2021
Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery 670 ES (Model H3100XF) - Prod…
GE Healthcare, LLC
FDA Devices Moderate Jan 20, 2021
GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope trac…
GE Healthcare, LLC
FDA Devices Moderate Jan 20, 2021
GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope trac…
GE Healthcare, LLC
FDA Devices Moderate Jan 20, 2021
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…
Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Jan 20, 2021
NaturaLyte Liquid Acid concentrate drums, Model Number 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarb…
Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Jan 20, 2021
Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended for use by cli…
Medtronic Neuromodulation
FDA Devices Moderate Jan 20, 2021
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1301-4 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…
Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Jan 20, 2021
Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049
Remel Inc
FDA Devices Moderate Jan 20, 2021
Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707
Cook Medical Llc
FDA Devices Critical Jan 20, 2021
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVSUS270, GTIN 08714729960928, M…
Boston Scientific Corporation
FDA Devices Critical Jan 20, 2021
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVS270, GTIN 08714729940838, Mad…
Boston Scientific Corporation
FDA Devices Moderate Jan 20, 2021
Citrasate Liquid Acid concentrate bottles, Product Code 08-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…
Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Jan 20, 2021
Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 - Product Usage: intend…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Jan 20, 2021
Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer …
GE Healthcare, LLC
FDA Devices Moderate Jan 20, 2021
The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection system for nucleic acids. Th…
Roche Molecular Systems, Inc.
FDA Devices Moderate Jan 20, 2021
Citrasate Liquid Acid concentrate bottles, Model Number 08-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…
Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Jan 20, 2021
Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarb…
Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Jan 20, 2021
VERITAS Collagen Matrix - Product Usage: intended for use in reconstruction of the pelvic floor excluding transvaginal pelvic organ prolapse and for …
Baxter Healthcare Corporation
FDA Devices Moderate Jan 20, 2021
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…
Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Jan 20, 2021
Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066000 - Product Usage: inten…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Jan 20, 2021
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…
Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Jan 20, 2021
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…
Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Jan 20, 2021
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2231-2 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…
Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Jan 20, 2021
Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of r…
Philips North America, LLC
FDA Devices Moderate Jan 20, 2021
Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (funct…
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Jan 20, 2021
Citrasate Liquid Acid concentrate drums, Product Code 13-2251 -CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicar…
Fresenius Medical Care Holdings, Inc.
FDA Devices Critical Jan 20, 2021
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVS250, GTIN 08714729940821, Mad…
Boston Scientific Corporation
FDA Devices Moderate Jan 20, 2021
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2301-3 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…
Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Jan 20, 2021
EXOGEN Ultrasound Coupling Gel
Bioventus, LLC
FDA Devices Moderate Jan 20, 2021
icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calc…
ICU Medical, Inc.
FDA Devices Moderate Jan 20, 2021
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3231-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…
Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Jan 20, 2021
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3201-4 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bica…
Fresenius Medical Care Holdings, Inc.
FDA Drug Moderate Jan 13, 2021
Lidocaine HCl 1% 10 mL (10mg/ml), Rx Only, 1 mL Single Dose Syringe, SCA Pharma, Inc., 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072012
SCA Pharmaceuticals
FDA Devices Moderate Jan 13, 2021
enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: intended for use in the in vitro quantitative measurem…
Ortho-Clinical Diagnostics, Inc.