Medical Device Recalls

Medline medical procedure kits, containing Medline Neuro Sponges (961 in total), NEURO,

Medline Industries, LP

EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.

Staar Surgical Company

The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to specifically block

Accriva Diagnostics, Inc.

Medline procedural kits labeled as: 1) BOTOX KIT - CHRONIC MIGRAINE, Pack Number DYKM2000; 2) BREAST, Pack Number D

MEDLINE INDUSTRIES, LP - Northfield

ECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS UTERINE SND GRD 13"STER25, Model Numbers: 96-247

Sklar Instruments

Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011; 2. H74904526052; 3. M00671

Boston Scientific Corporation

Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Versio

Qiagen Sciences LLC

a. Dynarex DRESSING, UNNA BOOT 3"X10' (12/CS), Catalog # 3453. b. Dynarex DRESSING, UNNA BOOT BANDAGE 4"X10' (12/CS)

Mckesson Medical-Surgical Inc. Corporate Office

Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84 Software Version: All software v

Abbott Laboratories

MEDLINE convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 2) BASIC BACK CDS, REF CDS7801

Medline Industries, LP

In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319

Abbott Molecular, Inc.

JAGTOME RX 44-20-450-035 Material Number: M00573050

Boston Scientific Corporation

Zenition 50 & 70 Mobile Surgery C-arm

Philips North America

medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1

Smiths Medical ASD, Inc.

Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe

Medline Industries, LP

ETEST CLINICAL IMIPENEM RELEBACTAM IPR US S30, CATALOG 420927

Biomerieux Inc

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR380 System, nuclear magnetic resonance sy

GE Healthcare, LLC

Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Vers

MicroPort Orthopedics Inc.

FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD FACSLyric" flow cytometer is intended for

Becton, Dickinson and Company, BD Bio Sciences

Halyard BIOPSY PACK - Medical convenience kits Model Number: VANW019-04

AVID Medical, Inc.

Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide catheter

Boston Scientific Corporation

Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781050

TELEFLEX LLC

Azurion 5 M20 System Code: (1) 722228 (2) 722232 (3) 722281

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Connecta¿ Plus 1 and Connecta¿ Plus 3 2-way and

BD SWITZERLAND SARL

Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bone Matrix

Medtronic Sofamor Danek USA Inc

API3200MD Mass Spectrometer, Part Number 4466230

AB Sciex, LLC

KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123

Karl Storz Endoscopy

Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;

Stryker GmbH

Hair Mineral Analysis

GET TESTED INTERNATIONAL AB

C9-4 Transducer Probe

Philips Ultrasound, Inc