Medical Device Recalls

(a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5 cm, Catalog #88-5910; (b) Care

Carefusion 2200 Inc

Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5, PDM, Programmed PT-00

Insulet Corporation

GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610

DePuy Orthopaedics, Inc.

PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724

VANTIVE US HEALTHCARE LLC

The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set t

Natus Medical Incorporated

SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM; 701114150/SUPERC

Argon Medical Devices, Inc

MEDLINE procedure kits labeled as follows: 1) NEURAXIAL KIT, REF PAIN1876A

MEDLINE INDUSTRIES, LP - Northfield

NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for facilitating the removal and r

NxStage MDS Corporation

TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical

DePuy Orthopaedics, Inc.

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG4 (5PK), REF H749085262532; cardiac catheter

Boston Scientific Corporation

Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental

Preat Corp

LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL KNEE PACK,

American Contract Systems, Inc.

Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper incl

ICU Medical Inc.

EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;

Boston Scientific Corporation

BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated Microbiology System, Catalog Numbers

Becton Dickinson & Co.

Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320. The TRAM is a powered lift device for transferring clien

Community Products, LLC

MEDLINE OPEN HEART NIMC KIT, REF DYNJ908840

MEDLINE INDUSTRIES, LP - Northfield

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

Philips North America Llc

SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMS

Medtronic Neuromodulation

DeRoyal CUSTOM NEURO PACK, REF 89-8392.09

DeRoyal Industries Inc

DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The DigniCap Scalp Cooling System User Manual

Dignitana, Inc.

Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242

Zimmer, Inc.

Arjo Portable Scale Adaptor, Model Number 700.05725; accessory intended to be used in combination with compatible patien

Arjohuntleigh Magog, Inc.

Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill,

Paragon 28, Inc.

Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Nu

Medline Industries, LP

EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when used as an

DePuy Spine, Inc.

CADD Administration Sets, Model #21-7346-24

Smiths Medical ASD Inc.

MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibrillator

Medtronic Inc.

Allura Xper FD10C; System Code: 722001;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Medline procedure kits, labeled as: NON STERILE I&D KIT, REF DYKM1438

MEDLINE INDUSTRIES, LP - Northfield