Medical Device Recalls

MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurgery

Megadyne Medical Products, Inc.

ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS12-

ConMed Corporation

ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US, CATALOG 400016

Biomerieux Inc

Ultraview SL (UVSL) Command Module, Model 91496

Spacelabs Healthcare, Inc.

Allen Life Assist Beach Chair, BCSSP-BEACH CHAIR , REF A-91501, #104002. For use with orthopaedic procedures using the

Baxter Healthcare Corporation

A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit

Windstone Medical Packaging, Inc.

Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Des

CooperSurgical, Inc.

CRTD DTPA2D1PX COBALT XT HF QUAD OUS, Model Number DTPA2D1PX; Implantable Cardioverter Defibrillators

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506540

TELEFLEX LLC

Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer

Beckman Coulter, Inc.

VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use in installation testing and rou

Steris Corporation

Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Catalog Number: QKN2461 Software Version: No

Tecfen Medical

Surpria: Software Version V3.11, V3.22

FUJIFILM Healthcare Americas Corporation

CRTD COBALT XT HF MRI IS1 DF1, Model Number DTPA2D1; Implantable Cardioverter Defibrillators

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

DeRoyal NEURO PACK, REF 89-9253.09

DeRoyal Industries Inc

ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70

ICU Medical, Inc.

Vue Motion V12. Product Number: 1017979.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140;

Philips North America Llc

Product Name: 25+ TTL PLUS VPAK 20000CPM BWV Model/Catalog Number: 8065830077 Software Version: N/A Product Descripti

Alcon Research LLC

Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Remington MEDICAL Drainage Bag, REF 600-D;

Remington Medical, Inc.

¿regard EYE TRAY, EY00099AE, Item Number 880099031; eye surgery convenience kit

ROi CPS LLC

Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14; 2) KIT,NEURO LAMI,MD ANDERSON

Cardinal Health 200, LLC

Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated

Siemens Healthcare Diagnostics, Inc.

ADVANTA VXT, 8X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

Total Knee Pack, REF CETJ130, medical convenience kits

American Contract Systems, Inc.

Merlin PCS 3650 programmer Model 3330 software

St. Jude Medical, Cardiac Rhythm Management Division

SmartPath to dStream for XR and 3.0T, Magnetic Resonance System.

Philips North America Llc

Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Baxter Vascular Probe, Product Codes: a) 7081015: 8CM, 1- 1.5 MM GLOBAL, b) 7081520: 8CM, 1.5-2 MM GLOBAL, c)

Baxter Healthcare Corporation