Medical Device Recalls

BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack

Bio-Rad Laboratories, Inc.

Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b. EXTRACTION PACK c. ORAL SURGERY PACK

MEDLINE INDUSTRIES, LP - Northfield

The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended len

Maquet Cardiovascular, LLC

Halyard POST PARTUM TUBAL LIGATION - Medical convenience kits Model Number: LANC026-19

AVID Medical, Inc.

Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-1

Mentor Texas, LP.

Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U

ARROW INTERNATIONAL Inc.

Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal fis

Cook Biotech, Inc.

ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and ch

Maquet Cardiovascular, LLC

COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786

Cook Incorporated

Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a horizontal position, Part Numb

Stryker Medical Division of Stryker Corporation

Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL

Covidien, LP

ProCurity bed series, model number 3009, item number: 3009PX-ZMX-600.

Stryker Medical Division of Stryker Corporation

Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, gene

Agfa N.V.

ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110

Philips North America Llc

SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 6011; SAFE-T-FILL

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) BRACHY THERAPY PROCEDURE PAC,

American Contract Systems, Inc.

FLIXENE, 4-7X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.

B Braun Medical Inc

Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) install

Foundation Medicine, Inc.

Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile

Stradis Healthcare

JAGTOME RX 49-20-260-035 Material Number: M00573000

Boston Scientific Corporation

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER S

Exactech, Inc.

Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09

BALT USA, LLC

PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-DS 45 40-S TLF-DS 45 45-S TLF-DS 55 30-

SPINEART SA

smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as foll

Smiths Medical ASD Inc.

Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088; 2) AV FISTULA PACK-LF, Pack Number DY

MEDLINE INDUSTRIES, LP - Northfield

Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended

Zyno Medical LLC

Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/C

Encore Medical, LP

Sterile surgical convenience kit: Medline Neuro IR Pack, Pack #DYNJ56073C, containing a Pure Pouch with component Me

MEDLINE INDUSTRIES, LP - Northfield

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Li

Elekta, Inc.