Medical Device Recalls

Digital Angiography System Bransist safire Generator Model D150GC-40

Shimadzu Medical Systems

Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-1

Encore Medical, LP

Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3.

Vortex Surgical Inc.

Vivoo Protein Test

Changchun Wancheng Bio-Electron Co., Ltd.

EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad

Elucent Medical Inc

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

B Braun Medical Inc

Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Per

TELEFLEX MEDICAL INC

Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial Vaginosis

Mckesson Medical-Surgical Inc. Corporate Office

Voalte Nurse Call System provides a comprehensive communication and information system that places patient calls, sta

Baxter Healthcare Corporation

Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL

Beckman Coulter Inc.

Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;

Abiomed, Inc.

ALLURA Xper FD10F; System Code: 722002;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Broch

Baxter Healthcare Corporation

HENRY SCHEIN, CATH PACK Item No.570-2789

Stradis Medical, LLC dba Stradis Healthcare

Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160

Olympus Corporation of the Americas

Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110

Boston Scientific Corporation

Brand Name: MEDLINE Product Name: SYR 5ML L/L RED Model/Catalog Number: 91825 Product Description: NON-Sterile syring

Jiangsu Shenli Medical Production Co., Ltd.

Description/REF: PICC ACCESS TRAY/ASK-04001-CG1

ARROW INTERNATIONAL, LLC

Medline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY, Kit SKU ACC010270A; 2) DRAWER 2, Kit SKU

Medline Industries, LP

Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6

Smiths Medical ASD Inc.

GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems

GE Medical Systems, SCS

Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a p

Zyno Medical LLC

BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2

Olympus Corporation of the Americas

GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with ho

W.L. Gore & Associates, Inc.

Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual)

Percussionaire Corporation

Baxter Spectrum IQ Infusion Pumps, Product code 3570009.

Baxter Healthcare Corporation

Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding

Abiomed, Inc.

Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of ¿2-microgl

Siemens Healthcare Diagnostics, Inc.

Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02

CELLTRION USA INC

VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACRO

Boston Scientific Corporation