Medical Device Recalls

Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter

Access Vascular, Inc.

Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes 2-8-2mm Spacing w/AutoID w/ EZ St

Medline Industries, LP

Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Sof

Ultradent Products, Inc.

Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay

Siemens Healthcare Diagnostics, Inc.

X5-1 Transducer Probe

Philips Ultrasound, Inc

Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.

Spacelabs Healthcare, Inc.

Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W

CooperSurgical, Inc.

Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body

Abiomed, Inc.

Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.

Stryker GmbH

N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 1044629

SIEMENS HEALTHCARE DIAGNOSTICS INC

Zoll, REF 8700-000871-40, Quattro (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer

ZOLL Circulation, Inc.

Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170080

TELEFLEX LLC

Cardinal Health Presource Kits: 1) KIT, H N FREE FLAP, Catalog Number: PEHFHNAMHJ; 2) KIT,H N FREE FLAP , Catalog Num

Cardinal Health 200, LLC

Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a pat

Zyno Medical LLC

REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130

Encore Medical, LP

GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

Burlington Medical, Half Aprons.

Burlington Medical, LLC

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-32-XX, Novation

Exactech, Inc.

Medline convenience kits containing semi-rigid suction liners labeled as follows: MERCY TIFFIN C-SECTION, Pack Number D

MEDLINE INDUSTRIES, LP - Northfield

Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog

Olympus Corporation of the Americas

PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701

VANTIVE US HEALTHCARE LLC

Brand Name: GMAX Product Name: SYR 10ML/LL syringe Model/Catalog Number: TS2210L-M Product Description: NON-Sterile s

Jiangsu Shenli Medical Production Co., Ltd.

NEO DELTA SELFSAFE PUR T, I.V. Catheter:

Delta Med SpA

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001546;

Beaver Visitec International, Inc.

Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 44cm FT10 SW Version 4.0.1.

Medline Industries, LP

MEDLINE convenience kits labeled as: 1) BURN, REF CDS983465M; 2) BURN, REF CDS983465N; 3) BURN PACK, REF DYNJ63331

MEDLINE INDUSTRIES, LP - Northfield

DeRoyal BASIC NEURO PACK, REF 89-7258.10

DeRoyal Industries Inc

Hobbs Helical Retrieval Basket Catalog Number: 4832

Hobbs Medical, Inc.

Penner Pacific Bathing Spa, Model Numbers 360020-1EP

Penner Patient Care, Inc.

ISee Ortho-K Lens

PARAGON VISION SCIENCES, Inc