Medical Device Recalls

REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2

Encore Medical, LP

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

B Braun Medical Inc

Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and

Hitachi Healthcare Americas Corporation

Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500

SEDECAL SA

ICD COBALT DR MRI IS1 DF4, Model Number DDPB3D4; Implantable Cardioverter Defibrillators

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid en

Olympus Corporation of the Americas

SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTF

Glycar SA Pty., Ltd.

Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5

Illumina, Inc.

DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620

Diasorin Inc.

Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS TRACHEOSTOMY TRAY, Reorder Number TC7470

MEDLINE INDUSTRIES, LP - Northfield

Medline brand medical procedure convenience kits, labeled as: 1) L&D/OB PACK-LF, REF DYNJ0213264O; 2) VAG DELIVERY HL

MEDLINE INDUSTRIES, LP - Northfield

ADVANTA VXT, 6X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft

Atrium Medical Corporation

Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042

Covidien LLC

Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504550

TELEFLEX LLC

Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007

Associates of Cape Cod, Inc.

SIGNA Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonan

GE Medical Systems, LLC

Prismaflex M Set: M150 (product code 109990). For use in providing continuous fluid management and renal replacement t

Baxter Healthcare Corporation

Hobbs Medical Polypectomy Snare Catalog Number: 4564

Hobbs Medical, Inc.

Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200.

FUJIFILM Healthcare Americas Corporation

ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE" BUCK EAR CUR BL STR#0STRLCS/25, Model Number

Sklar Instruments

Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000

Medicrea International

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-PLASTIC CRANIO

Medline Industries, LP

RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating

Cytocell Ltd.

Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS

MEDLINE INDUSTRIES, LP - Northfield

Freeman Pancreatic Flexi-Stent Kit Catalog Number: 6352

Hobbs Medical, Inc.

Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS CIRCUMCISION TRAY, Reorder Number CIT3345

MEDLINE INDUSTRIES, LP - Northfield

Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, BR

Philips Respironics, Inc.

Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to

Boston Scientific Corporation

Laser light show projectors manufactured by BLS, Model PURE 5000/10000.

Beyond Laser Systems, LLC

Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 S

Fresenius Medical Care Holdings, Inc.