Medical Device Recalls

EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base

MicroPort Orthopedics Inc.

Product Name: 25+ CMB PAK 10K CPM,V,WA 0.9 Model/Catalog Number: 8065752451 Software Version: N/A Component: N/A

Alcon Research LLC

Percept BrainSense Implantable Neurostimulator (INS), Model B35200

Medtronic Neuromodulation

Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK, REF DYNJ80370A; b) DR HEFZY BLOCK

MEDLINE INDUSTRIES, LP - Northfield

Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181060

TELEFLEX LLC

ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151

Siemens Healthcare Diagnostics, Inc.

NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)

Draeger Medical, Inc.

MEDLINE Medical Procedure Kits labeled as: CATH 22F ROBINSON STRL 5'S PK, Medline Kit Number/SKU DYNJ0040839

Medline Industries, LP

Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN STF-18-40-AUST G07304

Cook Incorporated

Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.

Abbott Molecular, Inc.

Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion

Covidien Llc

RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro diagnostic quality control material to m

Mechatronics USA

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.

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

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.