Medical Device Recalls

ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MC

Cordis US Corp

Small intestinal videoscope-For endoscopy and endoscopic surgery within the upper digestive tract (including the esophag

Aizu Olympus Co., Ltd.

Hillrom LikoScale component, Product Code 3156232, used with the following adapter kits for patient lifts: 1) LikoSc

Baxter Healthcare Corporation

Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space

B Braun Medical Inc

Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101 Chin Implant style 1 size 1

DSAART LLC

Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data recei

Braemar Manufacturing, LLC

RUMMELL, Medline Item No. ST006ST

MEDLINE INDUSTRIES, LP - Northfield

MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used wit

Volcano Corp

Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.

OSSTEM Implant Co., Ltd.

Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lock - Female Lock Guarded Luer Connector, St

International Medical Industries, Inc.

STRADIS HEALTHCARE, Surgical Pk, Item No.40649ECS, dental

Stradis Medical, LLC dba Stradis Healthcare

3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU2

Philips Ultrasound, Inc.

AirFit F20 Full Face Mask and User Guide

ResMed Ltd.

Allon 2001. Part Number: 200-00263

Belmont Instrument LLC

IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. Indicate

Philips North America Llc

Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fi

Cook Biotech, Inc.

MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use.

CooperVision, Inc.

Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) PUTTY T50101INT GRAFTON DBF 1CC, REF T50101

Medtronic Sofamor Danek USA Inc

NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF 8229506

Medtronic Xomed, Inc.

CombiDiagnost R90; Model Number: 709031;

Philips Medical Systems DMC GmbH

DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10

DeRoyal Industries Inc

CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbo

Maquet Medical Systems USA

Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430.

Wright Medical Technology Inc

DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit

DeRoyal Industries Inc

Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number: 728321. 2. Ingenuity CT 728326

Philips North America Llc

Arrow Three-Lumen CVC

ARROW INTERNATIONAL Inc.

The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total

BioReference Health, LLC

Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm Tapered to 7.4cm x 30cm), Non-Ster

Sheathing Technologies Inc

Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbishe

Beckman Coulter, Inc.

IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA

IMPRIS Imaging Inc