Medical Device Recalls

CLARITI 1 DAY TORIC -DIAGNOSTIC Power-07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker

CooperVision Inc.

Hanger-Bar 2P 45cm

Human Care USA, Inc.

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VEIN HOOK 1.5MM STERILE CS/25, Model Number 96-4020

Sklar Instruments

Impella CP Smart Assist Set, Canada; Product Code: 0048-0044;

Abiomed, Inc.

Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CHEST TUBE INSERTION TRAY, Reorder Number CVI2105;

MEDLINE INDUSTRIES, LP - Northfield

Medline convenience kits containing semi-rigid suction liners labeled as follows: ANES TURNOVER KIT-LF, Pack Number DYN

MEDLINE INDUSTRIES, LP - Northfield

Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121 Affini

Philips Ultrasound Inc

Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory

Baxter Healthcare Corporation

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K10

Merit Medical Systems, Inc.

Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322

Greiner Bio-One North America, Inc.

Trilogy Evo Universal Ventilator, Model Number DS2000X11B

Philips Respironics, Inc.

Discovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic Resonance Imaging System - research use only

GE Medical Systems, LLC

Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

Datascope Corp.

Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Des

Spacelabs Healthcare, Ltd.

Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes packaged in each.

Parker Laboratories, Inc.

Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044

Covidien LLC

OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02

American Contract Systems Inc

VITROS Performance Verifier II

Ortho-Clinical Diagnostics

Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148;

Philips North America Llc

Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL9

Medline Industries, LP

regard Operative LAP, Item Number 800943001; surgical convenience kit

ROi CPS LLC

BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number:

Becton Dickinson & Co.

Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Nu

Exactech, Inc.

Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter

Datascope Corporation

HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant K

Thoratec LLC

stay-safe /Luer Lock Catheter Ext. 12 in

Fresenius Medical Care Holdings, Inc.

Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.

Philips Respironics, Inc.

Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028

Covidien, LP

TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318

Tornier, Inc

Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80C, (2) G5A-80C-TSO. Software Version

ZOLL Medical Corporation