Medical Device Recalls

Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determi

Beckman Coulter Inc.

Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monit

Integra LifeSciences Corp.

Medline Convenience kits labeled as: 1) STERILE LIDOCAINE SYRINGE PACK, Pack Number DYNDM1076A ; 2) PEDIATRIC EP PA

MEDLINE INDUSTRIES, LP - Northfield

LOGIQ P10 series with software version R4.5.7 Model Number 5877534

GE Medical Systems, LLC

DeRoyal SPINE PACK, REF 89-8361.10

DeRoyal Industries Inc

ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.

Onkos Surgical, Inc.

Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can

Philips North America Llc

Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion

ICU Medical, Inc.

CRE Pro Wireguided 8-10mm 240cm

Boston Scientific Corporation

CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP

Smiths Medical ASD Inc.

ETEST CLINICAL FLUCONAZOLE FL 256 US S30, CATALOG 412333

Biomerieux Inc

IPS e.max ZirCAD CER/in. Prime A1 C17/5 - A zirconium oxide block for the fabrication of fixed, full-contour restoratio

IVOCLAR VIVADENT AG

Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revisi

Medtronic Neuromodulation

HXBL/WETEX/Genesis Biomedical Viral Transport Container, Custom Made

Haimen Shengbang Laboratory Equipment Co. Ltd.

OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment

Lacrimedics Inc

ETEST CLINICAL ERYTHROMYCIN EM 256 US S30, CATALOG 412333

Biomerieux Inc

Sterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SYRINGE PREFILLED 10 ML/6496722, 30CC PREFILL

Nurse Assist, LLC

Arial mobile application, model #54630 and #54640 for Android devices downloaded from the Google Play Store as part of t

Securitas Healthcare LLC

Single Shot Epidural Tray Catalog 1292

Busse Hospital Disposables, Inc.

FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787 The K170974 clearance document describes

Becton, Dickinson and Company, BD Bio Sciences

Arcos Modular Revision Hip System Standard Cone Prox Body, Size E, 70 MM Item Number:11-301325

Biomet, Inc.

Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55 cm, Item Code 8888

Covidien, LP

Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case

Medical Action Industries, Inc. 306

MiniMed insulin pump, REF: 700G (MMT-1801, MMT-1805, MMT-1850, MMT-1851)

Medtronic MiniMed, Inc.

Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures

Siemens Medical Solutions USA, Inc

Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water content, Toric, cast mo

CooperVision, Inc.

CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in v

Cytocell Ltd.

Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569; 2) OPEN HEART PEDS PACK, Model Number: DY

Medline Industries, LP

Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complications associated with immobil

Baxter Healthcare Corporation

Medline Convenience kits labeled as: 1) ZALE STEREOTACTIC CDS , Pack Number CDS983173G ; 2) ZALE OTOLOGY CDS, Pack

MEDLINE INDUSTRIES, LP - Northfield