Medical Device Recalls

Tenaculum, Plastic

Stradis Medical, LLC dba Stradis Healthcare

GE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers: 1) H3000WN; 2) H3000YM; 3) H3000YS; System, Tomography,

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118

Bard Access Systems, Inc.

Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedur

Siemens Medical Solutions USA, Inc

Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382060

TELEFLEX LLC

Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article N

I.T.S. GmbH

Infusomat UNIV. 15 DROP PUMP SET, 3 ULTRASITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV)

B. Braun Medical, Inc.

Philips Mini Multi TEE Ultrasound Transducer

Philips Ultrasound, Inc

ESG PK CUTTING FORCEPS, 5MM, 33CM

Olympus Corporation of the Americas

Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.

Aizu Olympus Co., Ltd.

CRTD DTMB2QQ AMPLIA MRI QUAD OUS DF4, Model Number DTMB2QQ; Implantable Cardioverter Defibrillators

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

CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323

Richard Wolf GmbH

Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;

Abiomed, Inc.

therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711

Qiagen Sciences LLC

BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), RE

Becton, Dickinson and Company, BD Bio Sciences

Medline Semi-rigid suction liners labeled as follows: a) SEMI RIGID SUCTION LINER, REF OR515; b) SEMI RIGID SUCTION L

MEDLINE INDUSTRIES, LP - Northfield

RATE FLOW set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa

B Braun Medical Inc

HENRY SCHEIN, Basin Pack, Item No.570-1692

Stradis Medical, LLC dba Stradis Healthcare

Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST

Remel Inc

Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat

B Braun Medical Inc

IntelliVue MP5. Product Number: M8105A.

Philips North America Llc

Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 3

Exactech, Inc.

OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.

Ossur Americas

HeartWare Ventricular Assist Device (HVAD) System

Heartware, Inc.

Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOFACIAL,PRES

Cardinal Health 200, LLC

a. DYNAREX Nice'n Fresh WIPE, BABY WET 6X6.75" (140/CN12CN/CS) Catalog # 1313. b. DYNAREX DynaCare WIPE, WET FLUSHA

Mckesson Medical-Surgical Inc. Corporate Office

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 0 DEGREE LINER 28MM 46MM,

Exactech, Inc.

smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201

Smith & Nephew, Inc.

QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18131-000; b) 18131-KIT; c) 18131-SET; radiation monitoring dosimete

Landauer

ADVANTA VXT, 7X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation