Medical Device Recalls

Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.

MEDLINE INDUSTRIES, LP - Northfield

CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519

Baxter Healthcare Corporation

ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)

Siemens Healthcare Diagnostics, Inc.

Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; Catalog No.: 10714009; Prod

Angiodynamics, Inc.

Medline convenience kits: DRIVELINE MANAGEMENT KIT EBSI1688 PORT DRESSING CHANGE KIT EBSI1328A

Medline Industries, LP

DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hem

Angiodynamics, Inc.

SIBO Test

GET TESTED INTERNATIONAL AB

Toothbrushes, labeled as: ORAL B TOOTH BRUSH SHINY CLEAN SOFT 12CT; COLGATE TOOTH BRUSH MED. 12CT; ADULT TOOTHPASTE W B

GOLD STAR DISTRIBUTION INC

Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11

Waldemar Link GmbH & Co. KG (Mfg Site)

Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479

Baxter Healthcare Corporation

Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and intervent

Siemens Medical Solutions USA, Inc

UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty. Catalog Number:

Howmedica Osteonics Corp.

Brand Name: Quantum Rehab Product Name: Quantum Rival Model/Catalog Number: Quantum Rival Software Version: 2.0.11, n

Pride Mobility Products Corp.

PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610

Limacorporate S.p.A

Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L

Medline Industries, LP

Infusomat 60 DROP METRISET PUMP SET,3 SFLINE ASV-Used with an electrically-powered infusion pump for intravenous (IV) ad

B. Braun Medical, Inc.

(1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX Expand, Model No. 866390 (3) PIC

Philips North America

HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) for in vitro agar diffusion

Hardy Diagnostics

MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay intended t

CARIS LIFE SCIENCES

Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology Calibrator (TOX CAL) is for in vitro diagnostic

Siemens Healthcare Diagnostics, Inc.

Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Soft

Kico Knee Innovation Company

Phoroptor VRx Digital Refraction System Model Numbers: 16242

Reichert, Inc.

Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX

Baxter Healthcare Corporation

Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog Number: CN

TruAbutment Inc.

Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.

Philips North America

Medline Convenience kits labeled as: SCS-LF, DYNJ902314D

MEDLINE INDUSTRIES, LP - Northfield

Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered lift device for transferring clients in a s

Community Products, LLC

Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201

Philips North America Llc

Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.

Olympus Corporation of the Americas

Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K16

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.