Medical Device Recalls

LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL

Bard Peripheral Vascular Inc

Medline convenience kits: ABD PACK DYNJ81673B BARIATRIC DYNJ902515K BARIATRIC + DYNJ904119O BARIATRIC CDS

Medline Industries, LP

HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-

HeartSine Technologies Ltd

ABBOTT DIAGNOSTICS PROBE CONDITIONING F/ARCHITECT ANLYZ ABBDIA SOLUTION.

Mckesson Medical-Surgical Inc. Corporate Office

RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. This is a web application software hoste

Roche Diabetes Care, Inc.

The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and el

Roche Diagnostics Operations, Inc.

Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;

Waldemar Link GmbH & Co. KG (Mfg Site)

Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;

Straumann USA LLC

Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Number: CDS983523G;

Medline Industries, LP

Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.

Philips North America Llc

Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with Manometer

Bard Peripheral Vascular Inc

BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70106.9078. A preconnected set used for extracorporeal respirat

Maquet Medical Systems USA

Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" HYDROGEL COATE

Cardinal Health 200, LLC

Optical Inspection System, YSi series, YRi series. Affected models: YSi-V, YSi-V(HS2), YRi-V

YAMAHA MOTOR CORPORATION

Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940

INSPIREMD Inc

ADVIA Centaur Erythropoietin (EPO) Assay (100 Test)

Siemens Healthcare Diagnostics, Inc.

Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610

Aesculap Implant Systems LLC

Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator

Medtronic Inc.

TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58, 1651-64, 1

LeMaitre Vascular, Inc.

MEDLINE LINQ TRAY, REF DYNJ65880A. Convenience kit used in medical/surgical procedures.

MEDLINE INDUSTRIES, LP - Northfield

Ovulation Test (5 tests)

GET TESTED INTERNATIONAL AB

OMNI III TEE Transducer Probe

Philips Ultrasound, Inc

NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL GSP30-0R-96-ENU-USL GSP30-ARA-INTL

Neilmed Pharmaceuticals Inc

GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030A09.07-0.01 Inten

Xcision Medical Systems, LLC

Procedure Tray Catalog 1065

Busse Hospital Disposables, Inc.

Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat, 5MM, 35CM, Front-

Olympus Corporation of the Americas

Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS IR INSTRUMENT TRAY, Reorder Number SUT10675

MEDLINE INDUSTRIES, LP - Northfield

Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.

Philips North America

Product Name: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU Model/Catalog Number: 8065000095 Software Version: N/A Component:

Alcon Research LLC

FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0

BioFire Diagnostics, LLC