Medical Device Recalls

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO CATH COMBINED PACK DYNJ43609S

Medline Industries, LP

Infinity FMS Pak

Alcon Research, LTD.

Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L YELLOW LIDO Model/Catalog Number: 91877 Product Description: NON

Jiangsu Shenli Medical Production Co., Ltd.

ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indicated for temporary internal fixation and sta

Zimmer, Inc.

Halyard IR ABCESS DRAINAGE PACK - Medical convenience kits Model Number: AVMD018

AVID Medical, Inc.

Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can pro

Philips North America Llc

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

Windstone Medical Packaging, Inc.

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

Stradis Medical, LLC dba Stradis Healthcare

DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00

Encore Medical, LP

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

InfuTronix LLC

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

Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133

Covidien, LP

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.

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.