Medical Device Recalls

GE Healthcare Innova IGS 5, computed tomography x-ray system

GE Medical Systems, SCS

Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300

Meridian Bioscience Inc

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000960;

Beaver Visitec International, Inc.

Medline CHEST TUBE REORDER NO: DYNJ36762A

Medline Industries Inc.

11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018)

Karl Storz Endoscopy

Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Catalog Number: 106015, HeartMate II¿ LVAS Ki

Thoratec LLC

Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Mon

Edan Diagnostics

VELYS Robotic-Assisted Solution Base Product No.: 451570100

DePuy Orthopaedics, Inc.

Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection i

Diagnostica Stago, Inc.

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM

Exactech, Inc.

Enhanced Verify Evaluation Handset (CFN HH90130FA)

Medtronic Neuromodulation

Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 80 MM Item Number: 11-301342

Biomet, Inc.

CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD1-6

Carefusion 2200 Inc

Brand Name: Wolf Medical Product Name: 60 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR

Jiangsu Shenli Medical Production Co., Ltd.

20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box

CellEra LLC

Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand

C.R. Bard Inc

BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Stryker Sustainability Solutions

Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2228

Cardinal Health 200, LLC

Stryker iBur 3.0mm Precision Match Head, Distal Bend- intended to cut bone in the following manner: drilling, reaming,

Stryker Corporation

Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultrasound transducer to tissue

Scrip Inc

MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)

Medtronic MiniMed, Inc.

Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model/Catalog Number: 37-3

Orthofix U.S. LLC

Exactech Novation Hip System, Catalog Numbers: 134-36-45

Exactech, Inc.

Cardioblate CryoFlex Surgical Ablation Console

Medtronic Perfusion Systems

BAUSCH + LOMB PHACO PACK, REF LYN011PHNHD. Convenience kit used in surgical procedures.

MEDLINE INDUSTRIES, LP - Northfield

Shoulder, SESH18I; Medical convenience kit

American Contract Systems, Inc.

Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra

Philips North America Llc

Medline Convenience kits labeled as: 1) MYELOGRAM PACK, Pack Number 00-399025L ; 2) BIOPSY PROCEDURE PACK , Pack Numb

MEDLINE INDUSTRIES, LP - Northfield

IntelliVue Multi Measurement Server X2. Product Number: M3002A.

Philips North America Llc

Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU CDS982901F; 2) NASAL PACK, SKU DYNJ17

MEDLINE INDUSTRIES, LP - Northfield