Medical Device Recalls

Univation X System knee implant devices as follows: Catalog/Product: NO156Z AS UNIVATION XF TIBIA CEMENTED T1 RM; N

Aesculap Implant Systems LLC

Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Desc

Greiner Bio-One North America, Inc.

Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnost

Abbott Molecular, Inc.

CVS PCSU SJH, REF SJCV48J

American Contract Systems, Inc.

S5-2 Transducer Probe

Philips Ultrasound, Inc

Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Cer

Ortho-Clinical Diagnostics, INc.

HENRY SCHEIN, ENT SET UP PACK, Item No.570-2742

Stradis Medical, LLC dba Stradis Healthcare

da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12

Intuitive Surgical, Inc.

cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for

Roche Diagnostics Operations, Inc.

Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Onl

Merit Medical Systems, Inc.

Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description

Trividia Health, Inc.

Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kit

American Contract Systems, Inc.

Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX

Datascope Corp.

Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Product Description: Infu

Integra LifeSciences Corp. (NeuroSciences)

Medtronic SynchroMed II, Model 8637-40, Programmable pump

Medtronic Neuromodulation

One Step P in vitro diagnostic test REF: 8194

DFI Co., Ltd.

Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888

Covidien, LP

Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0136-S 3.0mm

Acumed LLC

BF-XT160 EVIS EXERA Bronchovideoscope, Model No. BF-XT160

Olympus Corporation of the Americas

Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system

CareFusion 303, Inc.

ROBOTIC PROSTATECTOMY PACK. Medical convenience kit.

AVID Medical, Inc.

Blood/MacConkey Biplate 100/PK, Product Number R02049

Remel, Inc

a. Comply INDICATOR, COMPLY VAPOR GAS (250/BG 4BG/CS) 3M Model Number: 1248. b. 3M Attest INDICATOR, CHEMICAL VAPORIZ

Mckesson Medical-Surgical Inc. Corporate Office

EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of strictures in the alimentary tract in a

Olympus Corporation of the Americas

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Soft

RAYSEARCH LABORATORIES AB

Medline Kits, trays, and packs labeled as follows: a) BLOOD DRAW KIT, REF DYNDV2183A; b) LCPH LAB DRAW KIT, REF DYN

MEDLINE INDUSTRIES, LP - Northfield

MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH CDS, REF CDS983411J; 3) M

MEDLINE INDUSTRIES, LP - Northfield

Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR

Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha

Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis

Coloplast Manufacturing US, LLC

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ULTRASOUND PACK, Model Number

MEDLINE INDUSTRIES, LP - Northfield