Medical Device Recalls

CRT-D DTBB1Q1 VIVA QUAD S IS4/DF1 US, Model Number DTBB1Q1; Implantable Cardioverter Defibrillators

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

The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol f

Beckman Coulter Ireland, Inc.

ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized t

Ion Beam Applications S.A.

meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box. The ImmunoCard STAT! Rotavirus Immun

MEDLINE INDUSTRIES, LP - Northfield

Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acqui

EBI, LLC

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE JAPAN; the system utilizes an

Boston Scientific Corporation

COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator

Medtronic Inc.

ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R

Aesculap Implant Systems LLC

Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180045

TELEFLEX LLC

Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601), Sample Kit S711100

Aspen Surgical Products, Inc.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000508;

Beaver Visitec International, Inc.

RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbished)

Randox Laboratories Ltd.

BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10179 ENDO MD 38 10180 ENDO MD 41 10181 END

BioPro, Inc.

CryoValve SG Cryopreserved Pulmonary Human Heart Valve

Artivion, Inc

Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, Sterile EO

Windstone Medical Packaging, Inc.

Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734

Owens & Minor Distribution, Inc.

Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.

Siemens Healthcare Diagnostics, Inc.

THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS Indicated for open, laparoscopic (including singl

Olympus Corporation of the Americas

Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD

Covidien

Zoll, REF 8700-000766-01, Quattro IVTM Premium Disposable Pack and Start UP Kit (6 ft.)

ZOLL Circulation, Inc.

X7-2t Transducer Probe

Philips Ultrasound, Inc

Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFSPC-35-145 G09607

Cook Incorporated

Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term peri

Angiodynamics Inc. (Navilyst Medical Inc.)

The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific imp

Boston Scientific Corporation

IBS Test

GET TESTED INTERNATIONAL AB

Biodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fi

Cook Biotech, Inc.

Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individua

Blue Ortho

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: UNIVERSAL DRESSING & PPE KIT, M

MEDLINE INDUSTRIES, LP - Northfield

LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.

Physio-Control, Inc.

ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fuji

Erbe Medical, LLC