Medical Device Recalls

Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral v

ev3 Inc.

11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)

Karl Storz Endoscopy

The Cholestech LDX¿ System combines enzymatic methodology and solidphase technology to measure total cholesterol, HDL c

Alere San Diego, Inc.

SIGNA Pioneer nuclear magnetic resonance imaging system

GE Healthcare, LLC

XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.

XTANT Medical Holdings, Inc

MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit" REF: 8888345629

Covidien LP

Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO

GE Medical Systems, LLC

Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional de

ROUTE 92 MEDICAL INC

HENRY SCHEIN, Vas Reversal Pack, Item No.888-2549,

Stradis Medical, LLC dba Stradis Healthcare

EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.

Staar Surgical Company

Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for

Philips North America Llc

Procedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C Section B MHHS, Sterile.

Cardinal Health 200, LLC

ZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with central venous infusion capabi

ZOLL Circulation, Inc.

Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System

Orthalign, Inc

Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219

Prismatik Dentalcraft, Inc.

Endo-Model Replacement Plateau; Item Number: 15-0027/11;

Waldemar Link GmbH & Co. KG (Mfg Site)

Carefusion V. Mueller" CUSHING BAYONET BIPOLAR FORCEPS, 2.0MM TIP, INSULATED OVERALL LENGTH 7-1/2" (190MM), REF F-2004

Carefusion 2200 Inc

PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE

Aizu Olympus Co., Ltd.

DeRoyal MYELOGRAM PACK, REF 89-9304.05

DeRoyal Industries Inc

DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106

Encore Medical, LP

Brand Name: MEDLINE Product Name: SYR 10ML L/L GREEN Model/Catalog Number: 91831 Product Description: NON-Sterile syr

Jiangsu Shenli Medical Production Co., Ltd.

Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399

Alcon Research LLC

Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP

Pulmonx, Corp.

BD Pyxis(TM) Anesthesia Station 4000, REF: 338

CareFusion 303, Inc.

IntelliVue MP90. Product Number: M8010A.

Philips North America Llc

VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0

Ortho-Clinical Diagnostics, Inc.

HYDRATOME RX 44-20MM/450CM Material Number: M00583060

Boston Scientific Corporation

Medline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF, REF DYNJ47568B; 2) UROLOGY ROBOTIC, REF DY

MEDLINE INDUSTRIES, LP - Northfield

Ivenix Infusion System (IIS), Large Volume Pump LVP-0004

Fresenius Kabi USA, LLC

Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33 cm, Item Code 8888

Covidien, LP