Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,640 total recalls
Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.
Maquet Cardiovascular, LLC
Sensis Vibe Hemo
Siemens Medical Solutions USA, Inc
Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated an
Siemens Healthcare Diagnostics, Inc.
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 1.5T TwinSpeed MR System, nuclear magnetic
GE Healthcare, LLC
Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic
Datex-Ohmeda, Inc.
Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02;
AVID Medical, Inc.
Puritan Bennett 980 Series Ventilator, 980X2ESDIEC
Covidien Llc
CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FO
Smiths Medical ASD, Inc.
Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A
Medline Industries, LP
TOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AF
American Contract Systems Inc
Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Numbe
Integra LifeSciences Corp.
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy S
Elekta, Inc.
Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilat
Datex-Ohmeda, Inc.
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software V
Edwards Lifesciences, LLC
Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical sc
Paltop Advanced Dental Solutions Ltd
Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasik Kit AMS
Windstone Medical Packaging, Inc.
CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD3-
Carefusion 2200 Inc
VITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS, CATALOG 413437
Biomerieux Inc
Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head
Orascoptic Surgical Acuity
EVIS EXERA III Gastrointestinal Videoscope
Olympus Corporation of the Americas
Merlin 2 PCS MER37000 programmer Model MER3400 software
St. Jude Medical, Cardiac Rhythm Management Division
ADVANTA VXT, 6X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
Atrium Medical Corporation
LYFO Disk
Microbiologics Inc
Constancy (80 kVp) nanoDot D2DNN, Model Numbers: a) 18150-000 (EMEA number VKITCON002); b) 18150-KIT; radiation mon
Landauer
The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial
Sophysa S.A.
Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when di
Integra LifeSciences Corp. (NeuroSciences)
Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile hoists) Model/Catalog Number: 1430116,
ETAC A/S
Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.
ROi CPS LLC
GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and data with
GE Healthcare, LLC
VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single P
Percussionaire Corporation
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