Medical Device Recalls

Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12

HF Acquisition Co LLC

Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures. P

Beaver Visitec International, Inc.

Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YEARS) <55 lbs/25 kg,

Philips North America LLC

Alinity m System, Part Number: 08N53-002

Abbott Molecular, Inc.

Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean Ultrasonic

Microcare Medical

Fisher Wallace Stimulator Models FW-100 and FW-200

Fisher Wallace Laboratories Inc.

Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urolo

Boston Scientific Corporation

TRACKMASTER, TREADMILL TMX428CP 220V, MODEL NUMBER 317-07929

Full Vision Inc

Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780080

TELEFLEX LLC

Halyard ANGIO PACK - Medical convenience kits Model Number: WRNM047-05

AVID Medical, Inc.

One Step pH in vitro diagnostic test REF: 31I4P

DFI Co., Ltd.

Halyard TAH-BUNDLE - Medical convenience kits Model Number: LANC039-29

AVID Medical, Inc.

Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation Syst

Medtronic Inc

DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic

Beckman Coulter, Inc.

Power Over Fiber Base Module

Terex Utilities

Arial Call Station, Model Numbers CSK200 and CSK200MR, is a wireless, battery-operated call device installed inside resi

Securitas Healthcare LLC

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001411;

Beaver Visitec International, Inc.

ARIES HSV 1&2 Assay, Part Number/REF 50-10017

Luminex Corporation

Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2) ORTHO PLASTIC MICROVAS

Cardinal Health 200, LLC

Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1

Hamilton Medical AG

Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Contr

Abiomed, Inc.

INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right

Smith & Nephew Orthopaedics GmbH

Ultrasound EA (Ergonomic Advantage) table versions; G3 Multi-Specialty Echocardiography and Multi-Specialty with Electri

Oakworks Inc

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. MAJOR BASIN SET DYNJ85723

Medline Industries, LP

GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR450w 1.5T, Optima MR450w GEM system, nuc

GE Healthcare, LLC

ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model

Boston Scientific Corporation

Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid managem

Baxter Healthcare Corporation

Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm Double Bevel Slit, A

International Science & Technology, LP, DBA Diamatrix Ltd.

SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PT

Glycar SA Pty., Ltd.

Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only

Merit Medical Systems, Inc.