RecallHawk

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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