Medical Device Recalls

Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt support surfaces (Adapt Air, Adapt Air EX, Ada

Agiliti Health - Ellis

ColoSense Test Kit, Part No. 80-001, component of ColoSense test

Geneoscopy, Inc.

Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 m

Spectranetics Corporation

Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082100

TELEFLEX LLC

DeRoyal CATARACT PACK, REF 89-10086.05

DeRoyal Industries Inc

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter

Abbott

ICD-DR DDMB1D4 EVERA MRI XT IS-1/DF4 US, Model Number DDMB1D4; Implantable Cardioverter Defibrillators

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

Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog Number: 5081290; 5081291 Sof

Heraeus Medical GmbH (Dental Division)

SmartPath to dStream for 1.5T. Model (REF) Numbers 781260, 782112.

Philips North America

BD BBL Sensi Disc Clarithromycin- 15 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 2316

Becton Dickinson & Co.

Freeman Pancreatic Flexi-Stent Catalog Number: 6566

Hobbs Medical, Inc.

DA VINCI PACK URO/PROSTATE. Medical convenience kit.

AVID Medical, Inc.

S8-3 Transducer Probe

Philips Ultrasound, Inc

MEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 2) MAJOR LITHOTOMY PACK-LF

Medline Industries, LP

Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number:

Intuitive Surgical, Inc.

Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fi

Cook Biotech, Inc.

Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent.

Stanbio Laboratory, LP

0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/EMZ10091240

Nurse Assist, LLC

Halyard LAPAROSCOPY TRAY - Medical convenience kits Model Number: LANC006-25

AVID Medical, Inc.

Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy C

Spectranetics Corporation

Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-AT-012 (MT26403-0), STK-AT-013 (MT26403-0),

Dexcom, Inc.

MEDLINE INDUSTRIES Medline Catheter Insertion Tray Medline Foley Without Catheter Without Balloon Model Number: DYND

Mckesson Medical-Surgical Inc. Corporate Office

EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not S

Ortho8, Inc.

Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm) Product Code: 3408 Intended for

Cardinal Health

Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 s

Hologic Inc

Mammotrak Diagnostic Coil 3.0T

Philips North America Llc

smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6F

Smiths Medical ASD, Inc.

Exeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044

Howmedica Osteonics Corp.

cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190

Roche Molecular Systems, Inc.