Medical Device Recalls

Product Name: 25+ TOTALPLUSr CP PAK 20K CPM BWV .9 IU Model/Catalog Number: 8065000093 Software Version: N/A Componen

Alcon Research LLC

Spectral CT on Rails, Software Version 5.1.0, Model Number 728334

Philips North America

Medline Convenience Kits: 1) CENTRAL LINE UNIVERSAL INSERTI, Model Number: CVI3780; 2) LVAD DRIVELINE TRAY, Model Num

Medline Industries, LP

Azurion

Philips Medical Systems Nederland B.V.

LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02

ICU Medical, Inc.

Trial Tampon Box; Model Number: FG-TMP-REF04050504;

DAYE (ANNE'S DAY LTD)

Carefusion V. Mueller" SEMKIN BIPOLAR FORCEPS WITH STOP, 0.7MM TIP OVERALL LENGTH 5-1/2" (140MM), REF F-1040

Carefusion 2200 Inc

Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1

Siemens Healthcare Diagnostics, Inc.

KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent

King Systems Corp. dba Ambu, Inc.

Olympus Thunderbeat 5 mm, 10 cm, Inline Grip

Olympus Corporation of the Americas

Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;

Philips North America Llc

Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504585

TELEFLEX LLC

SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

Baxter Healthcare Corporation

SIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nucle

GE Medical Systems, LLC

VIDAS LH, REF 30406-01

bioMerieux, Inc.

BD BBL Sensi Disc Levofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231705

Becton Dickinson & Co.

ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136

ICU Medical, Inc.

Proteus 235; Version: PTS-8 versions before PTS-8.7.2

Ion Beam Applications S.A.

Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-FEM-CELECT-PT G34502; IGTCFS-65-1-JUG-CELEC

Cook Medical Incorporated

TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta

Datascope Corp.

a. DERMA SCIENCES, INC. NG Strip FASTENER, NASAL TUBE IND WRAP(25/BX), Catalog NG25. b. DERMA SCIENCES, INC. Surgi

Mckesson Medical-Surgical Inc. Corporate Office

WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and Broc

WAVi Co.

BIOPHEN UFH Control Plasma

Aniara Diagnostica LLC

Centurion hook kits labeled as: a) STERILE SKIN HOOK FINE (EA3975F), Product Code 66660; b) STERILE SMALL 2 PRONG SKI

MEDLINE INDUSTRIES, LP - Northfield

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 19-Indicated for patients with Mobility-limiting diseases, frac

Waldemar Link GmbH & Co. KG (Mfg Site)

LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Q

LumiraDx

Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthc

Turbett Surgical, Inc.

Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthropl

Stryker Orthopaedics

RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00

Reflexion Medical, Inc.

ICD-VR DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1; Implantable Cardioverter Defibrillators

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