Medical Device Recalls

Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH R-100

Fresh Roast Systems Inc

mint Lesion, Software Versions: 3.9.0 through 3.9.5.

Mint Medical GmbH

Sterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. BURN PACK-LF c. BURN PACK d. SMALL BURN

MEDLINE INDUSTRIES, LP - Northfield

Custom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE INSERTION PACK, kit number LLCE52;

American Contract Systems, Inc.

Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1

Medtronic Perfusion Systems

smiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093

Smiths Medical ASD Inc.

Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1

Sol-Millennium Medical Inc.

Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781060

TELEFLEX LLC

Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-

HeartSine Technologies Ltd

SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magne

GE Medical Systems, LLC

Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY , Catalog Numb

Cardinal Health 200, LLC

Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197

BioPro, Inc.

RayStation with the following product descriptions: 1. RayStation 9B, Software Version: 9.1.0.933. 2. RayStation

RAYSEARCH LABORATORIES AB

TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set.

B. Braun Medical, Inc.

CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K

Medtronic Sofamor Danek USA, Inc

Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml syringe on a

OriGen Biomedical, Inc.

EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory int

QUANTUM SURGICAL SAS

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:

Zimmer, Inc.

Constellation Procedure Pak

Alcon Research, LTD.

FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10

Edwards Lifesciences, LLC

Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 55

UIH Technologies LLC

BEAVER-VISITEC INTERNATIONAL, INC. Ultracell WICK, FENSTD PED 7MMX20MM(10/BX) BVRVIS Catalog #30316-C

Mckesson Medical-Surgical Inc. Corporate Office

YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide counter pulsation therapy in the aorta.

Datascope Corp.

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product Description: These ins

Olympus Corporation of the Americas

D&C pack

American Contract Systems, Inc.

SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321

Howmedica Osteonics Corp.

VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.

Canon Medical System, USA, INC.

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGI

MEDLINE INDUSTRIES, LP - Northfield

QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) sample

Qiagen GmbH

SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-01

WISSNER-BOSSERHOFF GMBH