Medical Device Recalls

Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001

Dexcom, Inc.

Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surg

Covidien, LP

Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Crome HF CRT-D, Model

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY

Merit Medical Systems, Inc.

Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205L-M Product Description: NON-Sterile sy

Jiangsu Shenli Medical Production Co., Ltd.

ARCH Leg Positioning System

Innovative Orthopedic Technologies, LLC

SURG PAT XRAY 1/2X3 Model/Catalog Number: 801407. The surgical patties and surgical strips are indicated for the use i

Integra LifeSciences Corp.

Discovery MR750w 3.0T

GE Medical Systems, LLC

Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B

Medline Industries, LP

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482EJ

Baxter Healthcare Corporation

DeRoyal BASIC EYE PACK, REF 89-8337.08

DeRoyal Industries Inc

Biofinity Toric Multifocal Contact Lens

CooperVision, Inc.

Halyard PACEMAKER INSTRUMENT PACK - Medical convenience kits Model Number: VAPX040-01

AVID Medical, Inc.

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NO-CATH RADIAL ARTERIAL PREMI

MEDLINE INDUSTRIES, LP - Northfield

Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode

Megadyne Medical Products, Inc.

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CUST

MEDLINE INDUSTRIES, LP - Northfield

CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into

Biosense Webster, Inc.

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DBD-

MEDLINE INDUSTRIES, LP - Northfield

uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection

Shanghai United Imaging Healthcare Co., Ltd.

Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2271418-5 Software Version: N/A Pro

Avanos Medical, Inc.

Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6

Stryker Instruments Div. of Stryker Corporation

Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood flow and other devices within the heart. M

Medline Industries, LP

Product Name: 25+ CMB PAK 7.5CPM,V,STD 0.9 Model/Catalog Number: 8065751767 Software Version: N/A Component: N/A

Alcon Research LLC

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM JAPAN; the system utilizes an interactive

Boston Scientific Corporation

syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Sim Model Number 11061660. Running on servers with syng

Siemens Medical Solutions USA, Inc

Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number: 500-106-5 Pectoral Implant sty

DSAART LLC

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000985;

Beaver Visitec International, Inc.

DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exud

ConvaTec, Inc

DxI 9000 Access Immunoassay Analyzer C11137

Beckman Coulter, Inc.

Sperm separation media are used to separate motile sperm from other constituents of semen.

Fujifilm Irvine Scientific, Inc.