Medical Device Recalls

PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx1

Angiodynamics, Inc.

ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; Implantable Cardioverter Defibrillators

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01

FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD

CustMbite, Model Number CBT-SRS-UL

Dental Choice Holding Llc

Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606

Medline Industries, LP

Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY AN

American Contract Systems Inc.

Brand Name: CORFLO Product Name: CORFLO Safety PEG Kit Model/Catalog Number: 30-5320

Avanos Medical, Inc.

Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-05

AVID Medical, Inc.

Vaginal Delivery, ASDV25B; Medical convenience kit

American Contract Systems, Inc.

Mycoplasma genitalium Control Panel (Inactivated Pellet)

Microbiologics Inc

Sterile Procedural Trays, labeled as the following: a. CELEBRATION ROBOTIC CDS b. DAVINCI CDS UCC-LF c. ROBOTICS

MEDLINE INDUSTRIES, LP - Northfield

Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040.

Stryker GmbH

MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroClave Clear Neutral Connector, Approx Priming

ICU Medical, Inc.

ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM

Cordis US Corp

Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-

ZOLL Medical Corporation

UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322

Beckman Coulter Inc.

PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS

Universal Meditech Inc.

Medline Convenience kits labeled as: 1) UROLOGY MINOR CDS , Pack Number CDS980371J ; 2) UROLOGY MINOR CDS , Pack Nu

MEDLINE INDUSTRIES, LP - Northfield

2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.

Fresenius Medical Care Holdings, Inc.

Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit", 12Fr., 48in Long, REF EN0046120

C.R. Bard Inc

Total Thyroxine (T4) ELISA; REF EIA-1781

DRG International, Inc.

CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteries installed as a

GE Healthcare Finland Oy

Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for I

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Custom procedural convenience kits and trays, ear, nose & throat, labeled as: a) T AND A PACK AGH ASC, kit number AGT

American Contract Systems, Inc.

Medline Convenience kits labeled as: 1) STEREOTACTIC BREAST BIOPSY TRA, Pack Number BT1095 ; 2) BREAST BIOPSY TRAY,

MEDLINE INDUSTRIES, LP - Northfield

ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip, 100mm Length. Catalog Number: iASB12-100. 6 units per pack

ConMed Corporation

Brand Name: MEDLINE Product Name: SYR 5ML L/L WHITE Model/Catalog Number: 91828 Product Description: NON-Sterile syri

Jiangsu Shenli Medical Production Co., Ltd.

SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; An empty single-use pouch made of plastic intended to contain

The Metrix Company

Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (BIC) - VERSION 2, Articl

B Braun Medical Inc

stay-safe /Luer Lock Catheter Ext. 18 in

Fresenius Medical Care Holdings, Inc.