Medical Device Recalls

Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in

Windstone Medical Packaging, Inc.

Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 1-LINE (CS 12) GREEN Model/Catalog Number: A

ASP Global, LLC.

STRADIS HEALTHCARE, Endo Pack, Item No.682-509,

Stradis Medical, LLC dba Stradis Healthcare

Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1

InfuTronix LLC

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. UROLOG

Medline Industries, LP

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

B Braun Medical Inc

COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part

Cook Incorporated

Centurion procedure kits, labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 2) ARTERIAL LINE T

MEDLINE INDUSTRIES, LP - Northfield

Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care enviro

Fresenius Kabi USA, LLC

MICS3 Angled Sagittal Saw Attachment; Part Number: 210490

Howmedica Osteonics Corp.

Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to au

Inpeco S.A.

GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B, ONE-CUF, SMALL ADULT, 1 TB BAYONET

GE Medical Systems Information Technologies Inc

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: CERVICAL PACK, Medline Kit Number

Medline Industries, LP

FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED352

MICROVENTION INC.

Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular ca

Medtronic Perfusion Systems

Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa

B Braun Medical Inc

REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile

Osteomed, LLC

Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001

Dexcom, Inc.

LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of le

Magellan Diagnostics, Inc.

NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290

Ansell Healthcare Products LLC

LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2230/06

Linkbio Corp.

SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708 73-3710 73-391

Howmedica Osteonics Corp.

OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM

Exactech, Inc.

Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX ser

Edan Diagnostics

Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksel

Elekta, Inc.

syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on servers with syngo.via

Siemens Medical Solutions USA, Inc

Cardiosave Rescue

Datascope Corp.

(1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II 9X Blood Lead Test Kit

Magellan Diagnostics, Inc.

SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0030

Howmedica Osteonics Corp.

HeartWare Model 1101

Heartware, Inc.