Medical Device Recalls

Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85

Datascope Corp.

Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK

Beckman Coulter Inc.

BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143

BioFire Diagnostics, LLC

ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during

Aesculap Implant Systems LLC

HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tracheal tube fixation device

MEDLINE INDUSTRIES, LP - Northfield

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001579;

Beaver Visitec International, Inc.

Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac t

Beckman Coulter, Inc.

Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35, IM

Insightra Medical Inc

Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Inte

NRT X-RAY A/S

Mammotome MammoStar Biopsy Site Identified, REF STAR1401

Carbon Medical Technologies, Inc.

QMS Tacrolimus Calibrators, Product code 10015573

Ortho-Clinical Diagnostics, Inc.

8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179

Intuitive Surgical, Inc.

REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest

Cellavision AB

VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS

Stradis Healthcare

Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, lifeline ECG,

Defibtech, LLC

Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App Model/Catalog Numbe

Dexcom, Inc.

Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system

Luminex Corporation

PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general so

Ethicon, LLC

Oncology sets with drip chambers

ICU Medical, Inc.

GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08

American Contract Systems Inc

Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Nu

Integra LifeSciences Corp.

MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750; MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1

Medtronic MiniMed, Inc.

IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x

Alphatec Spine, Inc.

Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl tran

Siemens Healthcare Diagnostics, Inc.

CENTURION MEDICAL PRODUCTS, LP Centurion CATH KIT, FML W/LUBE 8FR (50/CS) CNTURN Catalog # CKF105L

Mckesson Medical-Surgical Inc. Corporate Office

Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 34

Encore Medical, LP

Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

Thoratec Corp.

Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K1615

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in sampl

Beckman Coulter Mishima K.K.

smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714

Smiths Medical ASD, Inc.