Medical Device Recalls

TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog N

Howmedica Osteonics Corp.

ADVANTA VXT, 8X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)

GE Medical Systems China Co., Ltd.

Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical S

Windstone Medical Packaging, Inc.

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX, Part Number DDS1159B

Windstone Medical Packaging, Inc.

KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.

Microbiologics Inc

SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7514

Howmedica Osteonics Corp.

VERIQUICK PREGNANCY TEST 1CT, SKU 901260, 939504

Family Dollar Stores, Llc.

BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack

Bio-Rad Laboratories, Inc.

SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

Pediatric Heart SJH, REF SJPH34K

American Contract Systems, Inc.

AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE 42-58MM, product code SW117T. Used in spin

Aesculap Implant Systems LLC

Brand Name: GlideScope Core 15-inch FHD Model/Catalog Number: 0570-0437 Software Version: Core 15 FHD v1.7 and earlier

Verathon, Inc.

ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated

Siemens Healthcare Diagnostics, Inc.

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAM PACK-LF DYNJ21574J

Medline Industries, LP

Enterprise 1.5T, Model Number: 781145;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Num

Ortho-Clinical Diagnostics, Inc.

DeRoyal SPINAL FUSION PACK, REF 89-7515.13

DeRoyal Industries Inc

Infusomat SPACE PUMP SET 15 DROP W/2 SAFEDAY-Used with an electrically-powered infusion pump for intravenous (IV) admini

B. Braun Medical, Inc.

Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe- Shaped, 9 x 8 cm (3.6" x 3.1"). Intended fo

Covidien, LP

Medline Convenience kits, containing Shenli syringes, labeled as: 1) LOCAL PACK, Pack Number DYNJ34129C ; 2) FTMC L

MEDLINE INDUSTRIES, LP - Northfield

ADVANTA VXT, 6X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253;

Philips North America Llc

Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ENT HARVEST

Cardinal Health 200, LLC

ADVANTA VXT, 4-7X45, 2GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.

Integra LifeSciences Corp. (NeuroSciences)

AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for us

DERMASENSOR INC

Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay

Siemens Healthcare Diagnostics, Inc.

MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the

Siemens Medical Solutions USA, Inc