RecallHawk

Medical Device Recalls

FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.

13,633 total recalls

Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-

Maquet Medical Systems USA

Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080080

TELEFLEX LLC

Halyard SHOULDER PACK - Medical convenience kits Model Number: PANJ005

AVID Medical, Inc.

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. SPINE PROCEDURES PACK-LF, Medli

Medline Industries, LP

Starcam/Camstar; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

3M Steri-Drape, Medium Drape with Wide Adhesive Aperture, REF 1033, general surgery drape

3M Healthcare Business

Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Pak

Alcon Research LLC

Achieva 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can pro

Philips North America Llc

8MM,PROGRASP FORCEPS,IS4000 ¿ REF 470093

Intuitive Surgical, Inc.

MiniMed 670G Insulin Pump (U.S. and O.U.S. Version)

Medtronic MiniMed

MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, PASS Tray REF: 8888104

Covidien LP

Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. ANGIOGRAPHY CATH LAB, Medline Kit Number/

Medline Industries, LP

Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2; 2) 44WT-3; 3) 44WT-4; 4) 44WT-6

Baxter Healthcare Corporation

Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagul

Medtronic Navigation, Inc.

Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor

TELEFLEX LLC

QC (Cs-137) screened nanoDot D2DNS, Model Number 03067-OTO; radiation monitoring dosimeter used with the microSTAR reade

Landauer

Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number:

Integra LifeSciences Corp.

Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED 16MM JAW 5MM, 32CM, NON RATCHETED, REF SP90-7036; endoscopic surg

Carefusion 2200 Inc

Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and intervent

Siemens Medical Solutions USA, Inc

Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q

St. Jude Medical, Cardiac Rhythm Management Division

GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 / Dismount, c) 830 /, d) 830 / 5842894-20,

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.

Olympus Corporation of the Americas

(1) Medline Sterile Hand Pack, Item DYNJ63380A, 3 kits per case, contains BD Chloraprep Hi-Lite Orange, 26 mL Applicator

MEDLINE INDUSTRIES, LP - Northfield

Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351

Randox Laboratories Ltd.

SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2

PATH

GEO-MED KNEE ARTHROSCOPY PACK, REF 89-5795.07

DeRoyal Industries Inc

SOLTIVE Pro SuperPulsed Laser (TFL-SLS )

Olympus Corporation of the Americas

FISHER SCIENTIFIC Sure-Vue PIPETTE, RPR DISPENSING (500/PK) Catalog # 23038015

Mckesson Medical-Surgical Inc. Corporate Office

Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180060

TELEFLEX LLC

Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT

Covidien, LP

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