Medical Device Recalls

AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787,

Hollister Incorporated

DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q

DeVilbiss Healthcare LLC

Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging s

Siemens Medical Solutions USA, Inc.

Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2

Philips Respironics, Inc.

Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexibl

Olympus Corporation of the Americas

SURG PAT XRAY 3/4X3/4 Model/Catalog Number: 801401. The surgical patties and surgical strips are indicated for the use

Integra LifeSciences Corp.

THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including sing

Olympus Corporation of the Americas

MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Mode

Philips North America Llc

Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01.

Trividia Health, Inc.

TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserte

LeMaitre Vascular, Inc.

Sterile Procedural Trays, labeled as the following: MINOR BASIC PACK-LF

MEDLINE INDUSTRIES, LP - Northfield

KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE

Karl Storz Endoscopy

Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V

Invacare Corporation

Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I

ARROW INTERNATIONAL, LLC

GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999;

GE Healthcare (China) Co., Ltd.

Medline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ905000D; b) ENDO KIT, REF DYKE1462A; c) ENDO

MEDLINE INDUSTRIES, LP - Northfield

VIDAS Estradiol II, REF 30431-01

bioMerieux, Inc.

REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery P

W L Gore & Associates, Inc.

Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-475

Cardinal Health 200, LLC

Model Number U226, VISIONIST CRT-P EL

Boston Scientific Corporation

SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000

Siemens Medical Solutions USA, Inc

STRADIS HEALTHCARE, Phlebectomy Pack, Item No.682-001,

Stradis Medical, LLC dba Stradis Healthcare

Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100

Olympus Corporation of the Americas

Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A

Medline Industries, LP

iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616

Atrium Medical Corporation

OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02

Exactech, Inc.

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VAD/PICC IV KIT, Model Numbe

MEDLINE INDUSTRIES, LP - Northfield

PPM CLINICAL CRAPONNE CLINICAL CHROMID CANDIDA 20 PLATES, CATALOG 43631

Biomerieux Inc

Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component:

Draeger Medical, Inc.

Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.

OSSTEM Implant Co., Ltd.