Medical Device Recalls

VITROS XT 3400 Chemistry System, Catalog No. 6844458

Ortho-Clinical Diagnostics, Inc.

PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with 10mL Saline Fill), Catalog Number

Becton Dickinson & Company

BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES

CareFusion 303, Inc.

ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer P

Abiomed, Inc.

GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1) ASM000085; 2) ASM001092; 3) SYS000001

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X (IPN000328), cardiac pump

ARROW INTERNATIONAL Inc.

TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only

Johnson & Johnson Surgical Vision, Inc.

Baxter Electrocardiograph, ELI 380 -DCS21

Baxter Healthcare Corporation

LIFEPAK 35 ECG cable REF 11111-000041

Physio-Control, Inc.

BRONCHOVIDEOSCOPE OLYMPUS BF-Q170

Olympus Corporation of the Americas

Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable n

Medtronic Neuromodulation

Medline Kits, trays, and packs labeled as follows: a) BREAST PACK, REF DYNJ56344B; b) SEPTOPLASTY PACK WRO-LF, RE

MEDLINE INDUSTRIES, LP - Northfield

Ad-Tech TECH ATTACH Cable- Product Usage: Designed for the purpose of connecting these electrodes to third party monitor

Ad-Tech Medical Instrument Corporation

Herniatome, 17G x 15cm, Lumbar Type with with 20ga-30cm Introducer, Model Number 5091715

ADRIA SRL

ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of

Abbott Laboratories

A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 6H LT- Anatomic Lateral Fibula Plate, 6-hole, Left Intended for Fixation of fractu

Tyber Medical

Illumina NextSeq 550Dx, REF: 20005715, CE, IVD

Illumina, Inc.

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:

Zimmer, Inc.

ViewPoint; system, imaging processing, radiological

GE Healthcare GmbH

AESCULAP S4 Cervical Cross Connector, L26mm, S4C CROSS CONNECTOR FIXED 26MM, product code SW114T. Used in spinal fusion

Aesculap Implant Systems LLC

smiths medical medex HemoDraw Plus Closed Blood Sampling Set with LogiCal Pressure Monitoring System, Model Numbers: a)

Smiths Medical ASD Inc.

The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communic

Boston Scientific Corporation

Medline Convenience kits labeled as: 1) GER ARTH BASIN PK RFID-LF , Pack Number DYNJ0100999K ; 2) PEDIATRIC MAJOR BAS

MEDLINE INDUSTRIES, LP - Northfield

DeRoyal LAPINECTOMY PACK, REF 89-7198.10

DeRoyal Industries Inc

Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 9898031376

Philips North America Llc

GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit

Agilent Technologies, Inc.

ARTIS icono ceiling. Model Number: 11328100.

Siemens Medical Solutions USA, Inc

Zoll REF: 8700-0783-14 (IC-4593CO), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capab

ZOLL Circulation, Inc.

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Saf

Merit Medical Systems, Inc.

TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip i

Corin Ltd