Medical Device Recalls

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

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.

Cardiac Workstation 5000; Model Number: 860439;

Philips North America

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000266;

Beaver Visitec International, Inc.

3M Steri-Drape, Small Towel Drape, REF 1000NSD, general surgery drape

3M Healthcare Business

Freeman Pancreatic Flexi-Stent Kit (containing 6352) Catalog Number: 6321

Hobbs Medical, Inc.

Procedural Accessory Kit Catalog Number: 9665R2

Busse Hospital Disposables, Inc.

Fixone Biocomposite Anchor

Aju Pharm Co., Ltd.

Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Sev E_Vap. (S

Mindray DS USA, Inc. dba Mindray North America

Photera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders

Daavlin Distributing Company

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001118;

Beaver Visitec International, Inc.

Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description:

Nova Ortho-Med Inc