Medical Device Recalls

BD Pyxis MedStation 4000 REF: 303. Intended to securely store and dispense medications to a qualified and authorized he

CareFusion 303, Inc.

MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)

Medtronic MiniMed, Inc.

VITROS XT 3400 Chemistry System, Catalog No. 6844458

Ortho-Clinical Diagnostics, Inc.

PIE PAK Models: P2HC-A, P2HC-S, P2HC

Edermy LLC

Numerous models of nonsterile hemostatic forceps: (1) REF BH100R, Carrel Artery Forceps 85MM; (2) REF BH104R, Hartmann

Aesculap Inc

Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K1

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device

C.R. Bard Inc

FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test in

Biofire Defense

Pilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201; retractor

TELEFLEX LLC

The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total P

BioReference Health, LLC

LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2030/10

Linkbio Corp.

BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from c

Becton Dickinson & Co.

Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;

Straumann USA LLC

Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by the Activa RC (Model 37612) impla

Medtronic Neuromodulation

ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environment

ICU Medical, Inc.

Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number

Cardinal Health 200, LLC

Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal implant

Medtronic Sofamor Danek USA Inc

CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog number and product name: 1. CD5-3B, CON

Carefusion 2200 Inc

Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard, Lef

Acumed LLC

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001304;

Beaver Visitec International, Inc.

smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CA

Smiths Medical ASD, Inc.

ICD CROME DR MRI IS1 DF1, Model Number DDPC3D1; Implantable Cardioverter Defibrillators

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

Allura Xper FD10/10; Model Number: 722005;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Zoll, REF 8700-000867-01, Quattro IVTM Disposable Pack and Start UP Kit (6 ft.)

ZOLL Circulation, Inc.

B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV

Galt Medical Corporation

Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC; (2)3612-100 DRAIN, OASIS PEDI

Atrium Medical Corporation

1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible wit

Copan Italia

Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard Item

ROi CPS LLC

Flamingo Funnel Medium, Model Number SQ20012-02

SurgiSmoke Solutions

RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may

Smith & Nephew Medical, Ltd.