Medical Device Recalls

CRTD COBALT HF MRI IS1 DF4, Model Number DTPB2D4; Implantable Cardioverter Defibrillators

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

Procedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) Presource PBDS Cat. POCGANA11, Kit, ARN Ant

Cardinal Health 200, LLC

Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system c

Philips North America Llc

Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 31

Roche Diagnostics Operations, Inc.

STRADIS HEALTHCARE, Femoral, Vasc, Item No.686-142,

Stradis Medical, LLC dba Stradis Healthcare

Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)

LEICA BIOSYSTEMS NUSSLOCH GMBH

Identity Imprint PS Tibial Tray Size 4: Lot 540287

Conformis, Inc.

Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330

Zoe Medical Incorporated

Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261

Merit Medical Systems, Inc.

Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3.

Siemens Healthcare Diagnostics, Inc.

DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115

Medtronic Perfusion Systems

Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmw

LEICA BIOSYSTEMS NUSSLOCH GMBH

ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultra

ImaCor Inc.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001395;

Beaver Visitec International, Inc.

RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 M00575361 M00575381 M00575401 M00575441

Boston Scientific Corporation

3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030NS, general surgery drape

3M Healthcare Business

RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)

Randox Laboratories Ltd.

Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 12 MM, 83 MM Long Item Number: 113632

Biomet, Inc.

DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defect

Musculoskeletal Transplant Foundation, Inc.

Freeman Pancreatic Flexi-Stent Catalog Number: 6567

Hobbs Medical, Inc.

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

B Braun Medical Inc

Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638,

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

HENRY SCHEIN, VEIN TRAY, Item No.570-2738,

Stradis Medical, LLC dba Stradis Healthcare

Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software v

Abbott Laboratories

regard FOOT PACK, OR00123Y, Item Number 880118; orthopedic surgery convenience kit

ROi CPS LLC

smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy tubes, labeled as foll

Smiths Medical ASD Inc.

DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06

DeRoyal Industries Inc

SmartPath to dStream for 1.5T

Philips North America Llc

HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004

Access Vascular, Inc

Signature Laparoscopic Instruments, Debakey Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connect

Silex Medical, LLC