Medical Device Recalls

Medline Leg bag, REF URO12573

MEDLINE INDUSTRIES, LP - Northfield

MEDLINE convenience kits labeled as: 1) MAJOR VASCULAR-LF, REF CDS840232L; 2) AVF-LF, REF CDS840233I; 3) GENERAL AAA

MEDLINE INDUSTRIES, LP - Northfield

Surgical convenience kits labeled as: MEDLINE BREAST BIOPSY KIT, Reorder Number DYNDA1224B

MEDLINE INDUSTRIES, LP - Northfield

Refill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-REF18001800;

DAYE (ANNE'S DAY LTD)

Various C-section packs

American Contract Systems, Inc.

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL BLOCK TRAY, Medl

Medline Industries, LP

SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX

Townsend Design

StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system.

Nova Biomedical Corporation

Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.

Olympus Corporation of the Americas

Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053

AtriCure, Inc.

Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-

WANDERCRAFT SAS

Oncology sets with drip chambers

ICU Medical, Inc.

Eye and Ear Dropper, Product Code 67082

Apothecary Products, LLC

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) TOTAL JOINT, Model Number CDS9

MEDLINE INDUSTRIES, LP - Northfield

SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away

Boston Scientific Corporation

Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR IC

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

DRX Revolution Mobile X-Ray System

Carestream Health, Inc.

Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2. 782106(S), 3. 782137(S), 4. 781358(X), 5

Philips North America Llc

Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Model/Catalog Number: 7180-24

Avanos Medical, Inc.

Philips S5-2 Ultrasound Transducer

Philips Ultrasound, Inc

greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs

Greiner Bio-One North America, Inc.

Bard¿ Nasogastric Sump Tube with ENFit, 18Fr., 48in Long, REF EN0042180

C.R. Bard Inc

Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K13

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.

Stryker Spine

DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460

Beckman Coulter, Inc.

Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080060

TELEFLEX LLC

REGARD Ear Tray

ROi CPS LLC

Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G577

Cook Incorporated

Presource kits and trays, labeled as: 1) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC3; 2) Cardiovascular P

Cardinal Health 200, LLC

Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-

Waldemar Link GmbH & Co. KG (Mfg Site)