Medical Device Recalls

VITROS Immunodiagnostic Products Troponin I ES Reagent Pack

ORTHO-CLINICAL DIAGNOSTICS

HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care Technology

Stradis Healthcare

Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8mm OD, Serrated Cup-Intended for use in clinical

Olympus Corporation of the Americas

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.

Olympus Corporation of the Americas

Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410

Merit Medical Systems, Inc.

Medline convenience kits: a. VENOUS ACCESS PACK-LF, Model Number DYNJ36725B, Lot codes: 19UBB149, b. KIT LB SHUNT, Mod

MEDLINE INDUSTRIES, LP - SPT

Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK SINGLE PACK, REF DYNDA1360B;

MEDLINE INDUSTRIES, LP - Northfield

Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray system

SEDECAL SA

ICD-DR DDMD3D1 PRIMO MRI, Model Number DDMD3D1; Implantable Cardioverter Defibrillators

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

GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3) H3100TA; System, Tomography, Com

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER NUMBER (GPN):G07518. For vascul

Cook Incorporated

CRTD CROME HF QUAD MRI IS4 DF1, Model Number DTPC2Q1; Implantable Cardioverter Defibrillators

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

Halyard MANIFOLD CATH PACK - Medical convenience kits Model Number: VMED005-03

AVID Medical, Inc.

Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23

Applied Medical Resources Corp

Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation equipment, display m

Olympus Corporation of the Americas

Injection Needle, single cvd. 70 degrees, REF: 738750; Injection Needle, single cvd. 80 degrees, REF: 738752; Injection

Karl Storz Endoscopy

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.

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.