Medical Device Recalls

Puritan Bennett 980 Series Ventilator, 980X1ENNISB

Covidien Llc

Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and

RAYSEARCH LABORATORIES AB

DeRoyal KIT TOTAL HIP, REF 89-8861.07

DeRoyal Industries Inc

Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previ

Biomet, Inc.

MEDLINE ReNewal ENT Coblator II PROcise XP Wand,w/Integrated Cable Suction & Saline (Blue), Item Number REF EICA88720R

MEDLINE INDUSTRIES, LP - Northfield

Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indi

Outset Medical, Inc.

Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Ver

Aesculap Inc

Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610,

Heidelberg Engineering GmbH

Allura Xper series

Philips Medical Systems Nederland B.V.

Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300

C.R. Bard Inc

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL TRAY W/PENCIL POIN

Medline Industries, LP

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

Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.

Siemens Healthcare Diagnostics, Inc.

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.