Medical Device Recalls

VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021

Luminex Corporation

Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140

Datascope Corp.

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAPHY PACK-LF DYNJ0854485S

Medline Industries, LP

PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU

Aesculap Implant Systems LLC

Medline Convenience kits labeled as: 1) GYN ENDOSCOPY KIT , Pack Number CDS981309O ; 2) GB GENERAL ENDO , Pack Numb

MEDLINE INDUSTRIES, LP - Northfield

Artis Q biplane, Model Number 10848282

Siemens Medical Solutions USA, Inc

GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; System, Tomography, Computed, Emission

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with used with 3M Surgical Clipper Catalog Number

3M Company - Health Care Business

LiquaSonic Ultrasound Gel 5L, Model No. 001222

Athena Medical Products Inc

Halyard FOOT ANKLE PACK - Medical convenience kits Model Number: EUOR005-02

AVID Medical, Inc.

Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis

Coloplast Manufacturing US, LLC

Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Medium Mode

Checkpoint Surgical Inc

Welch Allyn CP150 Electrocardiograph:

Baxter Healthcare Corporation

Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082085

TELEFLEX LLC

ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: EL

Welch Allyn Inc Mortara

Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with correspon

Abiomed, Inc.

The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the inf

Micro Therapeutics, Inc.

CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236150 P4254108 PowerMidline Catheter 4 Fr Dual

Bard Access Systems, Inc.

Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega S

Megadyne Medical Products, Inc.

Allura Xper FD20/20 System Code: (1) 722038

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM

Howmedica Osteonics Corp.

Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.

AVID Medical, Inc.

Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection

Maquet Cardiovascular, LLC

API VP1 VP2 REAGENTS, CATALOG 70422

Biomerieux Inc

HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102

Heartware, Inc.

RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480040

TELEFLEX LLC

O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500

O&M HALYARD, INC.

Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098

Intuitive Surgical, Inc.

Phantom 2 Nasal Vented Mask

SleepNet Corporation

SmartPath to dStream for 1.5T, Magnetic Resonance System.

Philips North America Llc