Medical Device Recalls

namic convenience kits labeled as: 1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, REF 60010468; 2) MTS,RIGHT HEART,KIT,W/TRA

MEDLINE INDUSTRIES, LP - Northfield

X6-1 Transducer Probe

Philips Ultrasound, Inc

MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32

Datascope Corp.

Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW HEP/SALINE Model/Catalog Number: 91855 Product Description: NON

Jiangsu Shenli Medical Production Co., Ltd.

DeRoyal TRACECART POSTEROR LAMI MICRODISC TRACECART, REF 53-1960.02

DeRoyal Industries Inc

LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2020/46

Linkbio Corp.

Incisive CT, software version 5.0

Philips Healthcare

Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.

Trokamed GmbH

Medline Convenience kits labeled as: 1) NHP BREAST BIOPSY PACK, Pack Number DYNJ17400B; 2) BREAST BIOPSY TRAY, Pack

MEDLINE INDUSTRIES, LP - Northfield

The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator

GE Hangwei Medical Systems, Co. LTD

KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD cont

Microbiologics Inc

CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides pulmonary art

St. Jude Medical

Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Number ACC010369B; 2. ADULT ICU INTUBATI

MEDLINE INDUSTRIES, LP - Northfield

KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P

Microbiologics Inc

Artis zee biplane, Model Number 10094141

Siemens Medical Solutions USA, Inc

CareFusion V. Mueller TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 1.0MM TIP, STR, MED, INSULATED OVERALL LENGT

Carefusion 2200 Inc

Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit

Medline Industries, LP

Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndro

Philips Respironics, Inc.

ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a dental implant to provide support for prosthet

Hiossen Inc.

MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) MINOR EYE TRAY #81, REF DYNJ27466T.

Medline Industries, LP

Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include

SunMed Holdings, LLC

GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100

DePuy Orthopaedics, Inc.

Maquet Rolite OR Light Systems, Model Numbers and Catalog Numbers ROL PWDII50SF - ARDPWT309001A, ROL PWDII50SF - ARDPWT3

Getinge Usa Sales Inc

Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K1419

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Medline procedure kits labeled as: 1) CENTRAL LINE DRESSING KIT, Reorder number DYNDC3189; dressing change tray

MEDLINE INDUSTRIES, LP - Northfield

Flow-c Anesthesia System, model 6887700

Getinge Usa Sales Inc

medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT

Smiths Medical ASD, Inc.

C9-3v Transducer Probe

Philips Ultrasound, Inc

Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent Sur

Asensus Surgical Inc

Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic

Mindray DS USA, Inc. dba Mindray North America