Medical Device Recalls

Pediatric care bed; Product Designation: KayserBett IDA;

KAYSERBETTEN GMBH & CO. KG

Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71

Micro-X Ltd.

da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11

Intuitive Surgical, Inc.

CODMAN Disposable Perforator 11mm. Cranial Perforator.

Integra LifeSciences Corp. (NeuroSciences)

Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT S

Alcon Research, LLC

Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelch

MUNEVO GMBH

CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD S

Smiths Medical ASD Inc.

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H74908526862; cardiac catheter

Boston Scientific Corporation

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

B Braun Medical Inc

regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to

ROi CPS LLC

Universal Nerve Block Tray Catalog Number: 9818

Busse Hospital Disposables, Inc.

Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum

Siemens Healthcare Diagnostics, Inc.

Computed Tomography X-ray System, Model: uCT 550 with software

Shanghai United Imaging Healthcare Co., Ltd.

See RES for complete list. Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROT

Medline Industries, LP

Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack.

ROi CPS LLC

Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1-Line, Blue Model/Catalog Number: ASP-5640

ASP Global, LLC.

Brand Name: MEDLINE Product Name: SYR 10ML L/S Model/Catalog Number: 83081 Product Description: NON-Sterile syringes

Jiangsu Shenli Medical Production Co., Ltd.

Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;

Philips North America

Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F; 2) ENT PACK, Medline

Medline Industries, LP

GEM Premier 5000 PAK; Part No. 00055360011.

Instrumentation Laboratory

Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.

Centinel Spine, Inc.

SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of maligna

Cordis Corporation

HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF DYNJMBRC4B; tracheal tube fixation device

MEDLINE INDUSTRIES, LP - Northfield

ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Re

ICU Medical, Inc.

VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use

Ethicon, Inc.

Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.

Olympus Corporation of the Americas

VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP ARD568811911 VLT600SF AIM STP

Getinge Usa Sales Inc

DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF: 426-11-030

Encore Medical, LP

Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296

MEDLINE INDUSTRIES, LP - Northfield