Medical Device Recalls

Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fis

Cook Biotech, Inc.

B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.

B Braun Medical Inc

Hillrom Welch Allyn Spot Vision Screener VS100, marketed under the following models: a) SPOT VISION SCREENER,W/O CASE

Baxter Healthcare Corporation

Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023

Luminex Corporation

Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638,

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial c

Spectrum Medical Ltd.

6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-01

The Anspach Effort, Inc.

DeRoyal EMERGENT TRAUMA PACK, ref 89-9453.12

DeRoyal Industries Inc

Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-14-711 Product Descr

Encore Medical, LP

smiths medical medex CBSS 5 ml, zweifach proximaler Entnahmeport 60 cm, Model Number DPSHC0084

Smiths Medical ASD Inc.

Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium SuperPulsed Laser System Model/Catalog Num

Olympus Corporation of the Americas

SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK w

Medtronic Neuromodulation

ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412252

Biomerieux Inc

TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)

Boston Scientific Corporation

Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue STE, Sterile EO

Windstone Medical Packaging, Inc.

Intera 1.5T Power/Pulsar, Magnetic Resonance System.

Philips North America Llc

VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of free triiodothyronine (

QUIDELORTHO

Compella Bariatric Bed System

Baxter Healthcare Corporation

Plum Solo Precision IV Pump, 40001-0401

ICU Medical, Inc.

Impella CP intravascular micro axial blood pump, Product Number 0048-0032

Abiomed, Inc.

VIDAS CLINICAL VIDAS MEASLES IGG 60TESTS, CATALOG 30219

Biomerieux Inc

Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDHFA500Q Neutrino HF Cardiac Resynchroniza

Abbott Medical

Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.

INCIPIO DEVICES

Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet Model/Catalog Number: 31738 Product Descr

Integra LifeSciences Corp. (NeuroSciences)

Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 220135 Software Version: N/A Produc

Avanos Medical, Inc.

Sterile Procedural Trays, labeled as the following: a. ENDOSCOPY-LF b. SEPTO/ENDO

MEDLINE INDUSTRIES, LP - Northfield

MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 700G Insulin Pump, REF: MMT-1

Medtronic MiniMed, Inc.

HAMILTON-H900 Humidifier, Models: 950001, 950004

Hamilton Medical AG

Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA

LivaNova USA, Inc.

JAGTOME REVOLUTION RX 39-20-450-025 Material Number: M00584250

Boston Scientific Corporation