Medical Device Recalls

MAXXUS, System, Tomography, Computed, Emission

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components: PT-127

TELEFLEX MEDICAL INC

ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 016

Boston Scientific Corporation

Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only

Merit Medical Systems, Inc.

MiniMed 700G Insulin Pump (MMT-1801, MMT-1805, MMT-1850, MMT-1851)

Medtronic MiniMed, Inc.

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

Olympus Corporation of the Americas

regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003

ROi CPS LLC

Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062; Nimbus II Plus IT1078; Nimbus II EpiD I

InfuTronix LLC

MAGNETOM Cima.X Upgrade. Model Number: 11689304.

Siemens Medical Solutions USA, Inc

TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental

STRATASYS LTD

Colonoscope, Model Number PCF-H190L.

Olympus Corporation of the Americas

SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML L

North American Diagnostics

Centurion procedure packs, containing Caina syringes, labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6860A; 2) R

MEDLINE INDUSTRIES, LP - Northfield

Olympus BRONCHOVIDEOSCOPE BF Type, Model Numbers BF-P150, BF-1T150

Olympus Corporation of the Americas

Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).

Abbott

Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY).

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Centurion brand, medical procedure convenience kits, labeled as: a) FLOOR - UMBILICAL CUT DOWN TRA, b) PLASTICS SUTUR

MEDLINE INDUSTRIES, LP - Northfield

Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in ho

Philips Respironics, Inc.

Surgical convenience kits labeled as: MEDLINE SHOULDER SUSPENSION I-LF, Reorder Number DYNJSHOULDER

MEDLINE INDUSTRIES, LP - Northfield

Philips L9-3 Transducer.

Philips Ultrasound, Inc

Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.

SIGHT DIAGNOSTICS LTD

Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Re

Hologic, Inc.

Medline Convenience kits labeled as: 1) LAVH CDS, Pack Number CDS760049AB; 2) TUBAL LIGATION CDS, Pack Number CDS7600

MEDLINE INDUSTRIES, LP - Northfield

Hobbs Posi-Stop Injection Needle Catalog Number: 4712

Hobbs Medical, Inc.

Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03 Software Version: All software v

Abbott Laboratories

Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in making d

Edge Biologicals Inc

Corin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw, REF 321.035, Sterile; and Corin Trinity Screw, d

Corin Ltd

RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO10125

Collagen Matrix, Inc.

Medline Convenience kits labeled as: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ; 2) DIALYSIS CATH ACCESS

MEDLINE INDUSTRIES, LP - Northfield

BD Pyxis MedFlex 2.0 REF 1139-00 Bio-ID Spare Parts REF 353200-01 The BD Pyxis" MedFlex is an Automated Dispensing

CareFusion 303, Inc.