Medical Device Recalls

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

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CATARACT FULL BODY DYNJ85743 M

Medline Industries, LP

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

TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog

Howmedica Osteonics Corp.

48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R

Smiths Medical Asd Inc

Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE

Shirakawa Olympus Co., Ltd.

Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator

Hamilton Medical, Inc.

VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 9

Ortho-Clinical Diagnostics, Inc.

Hobbs Medical Cytology Brush Catalog Number: 4204

Hobbs Medical, Inc.

BETTA LINK SR REUSABLE PRONGED GUIDE- Intended for use in soft tissue to bone fixation in the repair of the natural liga

T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.

SmartPath to dStream for 3.0T Model Number (REF): 782145;

Philips North America

Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0C

Diasol, Inc

Intera 1.5T Achieva IT Nova, Magnetic Resonance System.

Philips North America Llc

Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.

Aerin Medical, Inc.

Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femo

Smith & Nephew, Inc.

ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150

Philips North America

DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-911

Howmedica Osteonics Corp.

Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.

Abbott

OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40

Olympus Corporation of the Americas

Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Descript

Edan Diagnostics

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25,Model Number 94-0286;

Sklar Instruments

LAVH PACK. Medical convenience kit.

AVID Medical, Inc.