Medical Device Recalls

Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700(IPN917285), cardiac pump

ARROW INTERNATIONAL Inc.

KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination board/large Model Number: 2001155-F

Klinika Mdical Gmb

Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-LF, REF CDS860235L; 2) GENERAL LAPAROSCOP

Medline Industries, LP

DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for us

Beckman Coulter Inc.

CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30

Terumo Cardiovascular Systems Corporation

BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF: 515003 BD PhaSeal Injector Luer

BD SWITZERLAND SARL

TRACKMASTER, TREADMILL TMX428 110V, MODEL NUMBER 317-07926

Full Vision Inc

Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immu

Randox Laboratories Ltd.

smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76

Smiths Medical ASD, Inc.

Gut Microbiome Test Mega

GET TESTED INTERNATIONAL AB

VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022

Luminex Corporation

Philips Avalon Fetal Monitor, FM 30 Part numberM2703A

Philips North America Llc

CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X

Philips North America

BD BBL Sensi Disc Augmentin - 3¿g, Catalog Number 291270¿used for semi-quantitative in vitro susceptibility testing.

Becton Dickinson & Co.

AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640

Boston Scientific Corporation

CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm), Model 44102, Sterile, Hypoallergeni

Cardinal Health 200, LLC

Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)

Getinge Usa Sales Inc

DeRoyal ACDF PACK, REF 89-8779.03

DeRoyal Industries Inc

BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for semi-quantitative in vitro susceptibility t

Becton Dickinson & Co.

Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF;

DAYE (ANNE'S DAY LTD)

Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500E (IPN000322), cardiac pump

ARROW INTERNATIONAL Inc.

LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2230/12

Linkbio Corp.

Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.

Tornier S.A.S.

epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, C

Siemens Healthcare Diagnostics Inc

SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

BD BBL Sensi Disc Ceftazidime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231632¿

Becton Dickinson & Co.

Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices

Globus Medical, Inc.

Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) runni

Philips North America

Model Number 40KWFXPLUS.005, Mobile X-ray system

SEDECAL SA

Freeman Pancreatic Flexi-Stent Kit (containing 6567) Catalog Number: 6519

Hobbs Medical, Inc.