Medical Device Recalls

Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part N

Wondfo USA Co Ltd

Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical

Baxter Healthcare Corporation

NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01

Zimmer, Inc.

SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0028

Howmedica Osteonics Corp.

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC INFANT INSERTION PACK, Mod

MEDLINE INDUSTRIES, LP - Northfield

THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrop

Johnson & Johnson Surgical Vision, Inc.

Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is emp

Healgen Scientific Llc

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236

Sklar Instruments

DeRoyal TOTAL KNEE PACK, REF 89-9300.08

DeRoyal Industries Inc

Omnipod 5 Automated Insulin Delivery System

Insulet Corporation

Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.

Olympus Corporation of the Americas

Burlington Medical, Vest

Burlington Medical, LLC

Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-16-PK Sof

Rocket Medical Plc

NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath Shep

Stryker Corporation

smiths medical Medfusion Model 4000 syringe pump

Smiths Medical ASD Inc.

i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngosc

Intersurgical Inc

HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoined Suction and Irr

Davol, Inc.

COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibrillator

Medtronic Inc.

Description/REF: ACCESS TRAY/ASK-04001-JHH; ACCESS TRAY/ASK-04001-LMDTG; PI CVC KIT: 3 LUMEN 7 FR X 6 IN (16 CM)/ASK-127

ARROW INTERNATIONAL, LLC

epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9. Intended for use by tra

Siemens Healthcare Diagnostics, Inc.

stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

Tornier S.A.S.

Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-

Medivance Inc.

Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasophary

Aizu Olympus Co., Ltd.

STRADIS HEALTHCARE, Surg Pack, Item No.40450SMS, dental

Stradis Medical, LLC dba Stradis Healthcare

Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vasc

Atrium Medical Corporation

Sterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC b. KNEE ARTHROSCOPY PACK

MEDLINE INDUSTRIES, LP - Northfield

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pump

ARROW INTERNATIONAL Inc.

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL3 (5PK), REF H749085261002; cardiac catheter

Boston Scientific Corporation

CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU-ID 900260

Family Dollar Stores, Llc.

Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. M

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.