Medical Device Recalls

BF-N20 OES Bronchofiberscope, Model No. BF-N20

Olympus Corporation of the Americas

Univation X System knee implant devices as follows: Catalog/Product: NL476 UNIVATION F MENISCAL COMP.T1 RM/LM 8MM; N

Aesculap Implant Systems LLC

Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code: (01)10801902159578(17)270531

ARROW INTERNATIONAL, LLC

TRACH PACK. Sterile Procedural Tray.

MEDLINE INDUSTRIES, LP - Northfield

NAD Profile Test

GET TESTED INTERNATIONAL AB

Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 200 2 in x 2 in / 5.1 cm x 5.1 cm Model Num

Steris Corporation

Vitamin D2 and D3 Test

GET TESTED INTERNATIONAL AB

STRADIS HEALTHCARE, Breast, Item No.693-276,

Stradis Medical, LLC dba Stradis Healthcare

Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)

Lusys Laboratories, Inc.

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item C

Smiths Medical ASD Inc.

MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01

MicroSurgical Technology Inc

Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)

Thoratec Corp.

EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359

Philips North America Llc

Intera 1.5T Power/Pulsar, Model Number: 781105;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

GE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 12 Holes, 184 MM, Sterile- Indicat

Zimmer, Inc.

ADVANTA VXT, 5-8X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60

CareFusion 303, Inc.

GEM Premier 5000; Part No: 00055415011.

Instrumentation Laboratory

Halyard SAMMC ANGIOGRAPHY - Medical convenience kits Model Number: SAMM066-15

AVID Medical, Inc.

The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.

DIXI MEDICAL USA

MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) TOTAL JOINT, Model Number CDS985555S; b) TOTAL KNEE,

MEDLINE INDUSTRIES, LP - Northfield

Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems

Beckman Coulter Inc.

Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can pro

Philips North America Llc

MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I; 2) ENT MINOR, REF CDS983466L; 3) EAR,

MEDLINE INDUSTRIES, LP - Northfield

Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Infant Intub

Oridion Medical 1987 Ltd.

OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.

IsoTis OrthoBiologics, Inc.

BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2.2MM DRILL BIT], [ALPS Drill Bit, Item #

Biomet, Inc.

MICRO-X Rover Mobile X-ray System, # MXU-RV35

Micro-X Ltd.

Outlook OUTLOOK PUMP SET,3 CARESITE LADS,115 IN. Used with an electrically-powered infusion pump for intravenous (IV) ad

B. Braun Medical, Inc.