Medical Device Recalls

Freeman Pancreatic Flexi-Stent Catalog Number: 6544

Hobbs Medical, Inc.

CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU 900260

Family Dollar Stores, Llc.

QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18130-000; b) 18130-KIT; c) 18130-SET; radiation monitoring dosimete

Landauer

Medline brand, medical procedure convenience kits, labeled as: 1) CRANIOTOMY, SKU CDS982719X; 2) MVFF/FIBU #54-RF, SKU D

MEDLINE INDUSTRIES, LP - Northfield

ICD-VR DVBC3D1 EVERA S IS1/DF1 GLOB, Model Number DVBC3D1; Implantable Cardioverter Defibrillators

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

Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154;

Mirion Technologies (Capintec), Inc.

X3 TRIATHLON CS INSERT NO 6 10 MM

Howmedica Osteonics Corp.

COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order Number G44

Cook Incorporated

Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple accessory configurations to include:

SunMed Holdings, LLC

DeRoyal POSTERIOR LAMI MICRODISC PACK, REF 89-10059.02

DeRoyal Industries Inc

SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-0710

Howmedica Osteonics Corp.

Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses

Augustine Temperature Management, LLC

Getinge Flow-e Anesthesia System, Part No. 6887900

Getinge Usa Sales Inc

OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult

POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC

Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that transmits Ho:YAG laser energy f

Boston Scientific Corporation

LAPAROSCOPIC TRAY. Medical convenience kit.

AVID Medical, Inc.

GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery

GE Healthcare, LLC

Hobbs Helical Retrieval Basket Catalog Number: 4824

Hobbs Medical, Inc.

Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010

Boston Scientific Corporation

Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to he

Advanced Medical Solutions Ltd.

FUSION Dual Pump Packs, REF: OPO73

Johnson & Johnson Surgical Vision, Inc.

Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent Graft System Model/REF ENBF2313C

Medtronic Vascular, Inc.

MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 16 Fr, 1000mL, Medline Product Number/SKU (RE

Medline Industries, LP

Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637

Siemens Healthcare Diagnostics, Inc.

Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506545

TELEFLEX LLC

SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Con

Cardinal Health 200, LLC

HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of O

Boston Scientific Corporation

Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.

Philips North America

regard ACDF, NU00698H, Item Number 800246008; neuro surgery convenience kit

ROi CPS LLC

Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6

Medtronic Inc