Medical Device Recalls

Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number -

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OPEN HEART CDS PART A, Medli

Medline Industries, LP

ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354R1

Busse Hospital Disposables, Inc.

POLIGRIP ADH CREAM FREE 2.4OZ, SKU 900334 POLIGRIP DENTURE ADHESIVE ORIGINAL 2.4OZ, SKU 900723 SUPER POLIGRIP ADH CREA

Family Dollar Stores, Llc.

IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 For

Siemens Healthcare Diagnostics, Inc.

Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO

Windstone Medical Packaging, Inc.

DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiogr

Carestream Health, Inc.

Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L

Tomy International Inc.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001305;

Beaver Visitec International, Inc.

Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782

Philips North America

MC3 VitalFlow Console, REF 58100; Blood pump of ecmo

Medtronic Perfusion Systems

Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107

Straumann USA LLC

Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)

Cook Incorporated

CRE Pro Wireguided 6-8mm 240cm

Boston Scientific Corporation

8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172

Intuitive Surgical, Inc.

Halyard ANTERIOR HIP PACK - Medical convenience kits Model Number: EUOR001-06

AVID Medical, Inc.

The Oncology Essentials Package of the Spectral CT imaging system.

Philips North America Llc

Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, 29HC20150ST, CE 2797, STERILE

Merit Medical Systems, Inc.

Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;

Philips North America Llc

Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2230

Cardinal Health 200, LLC

Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ST150 (product code 107640). For use in pr

Baxter Healthcare Corporation

Medline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kit

MEDLINE INDUSTRIES, LP - Northfield

Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380055

TELEFLEX LLC

NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-

Northeast Scientific Inc.

Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF:

Bard Peripheral Vascular Inc

KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A

Karl Storz Endoscopy

Medical Monofilament Manufacturing MONOFILIMENT TEST, SENSORY F/FOOT 10GM (40/PK) Model Number: AM140

Mckesson Medical-Surgical Inc. Corporate Office

Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.

Mozarc Medical US LLC