Medical Device Recalls

Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.

Olympus Corporation of the Americas

VIDAS FSH, REF 30407-01

bioMerieux, Inc.

BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am,

Axonics Modulation Technologies, Inc.

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H7490852624; cardiac catheter

Boston Scientific Corporation

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584550;

Beaver Visitec International, Inc.

OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I

American Contract Systems Inc

Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9.1.0, 9.2.0, 10.0.0, 10.0.1, 10

RAYSEARCH LABORATORIES AB

Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232

Howmedica Osteonics Corp.

Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument

restor3d Inc.

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180

Olympus Corporation of the Americas

SS 4.5MM DIAMOND TIP TROCAR WITH LARGE GLOVES Catalog Number:B1559

Busse Hospital Disposables, Inc.

HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatme

Olympus Corporation of the Americas

Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080100

TELEFLEX LLC

Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 1120

Siemens Healthcare Diagnostics, Inc.

da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40

Intuitive Surgical, Inc.

Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF SU130-4601

Cardinal Health 200, LLC

Model Number L101, ESSENTIO DR SL Pacemaker

Boston Scientific Corporation

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000910;

Beaver Visitec International, Inc.

Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Number

ICU Medical Inc

ProxiDiagnost N90. radiography and fluoroscopy system

Philips Medical Systems DMC GmbH

Brand Name: MEDLINE Product Name: SYR 10ML L/L RED HEPARIN Model/Catalog Number: 91851 Product Description: NON-Steri

Jiangsu Shenli Medical Production Co., Ltd.

ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25, Model Number 941-0191 (trache

Sklar Instruments

Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessories (simple, powere

SURGIFY MEDICAL OY

prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5

Centinel Spine, Inc.

Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859,

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurio

Philips North America Llc

Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w

ROi CPS LLC

SURG PAT XRAY 3X3 Model/Catalog Number: 801409. The surgical patties and surgical strips are indicated for the use in

Integra LifeSciences Corp.

DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443

Encore Medical, LP

8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System

B. Braun Medical, Inc.