Medical Device Recalls

BD Recanalization System, REF: BDRECANSYSTEM

Bard Peripheral Vascular Inc

OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM UDI

Bard Access Systems, Inc.

Intera 1.5T, Model No. 781195

Philips North America

Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 84021B Kendall S

Cardinal Health 200, LLC

Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331

Zoe Medical Incorporated

DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. Each DASH SARS-

Nuclein LLC

RayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.1547. 2. RayStati

RAYSEARCH LABORATORIES AB

Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal. Intended for patients requiring endotracheal intubat

TELEFLEX LLC

Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Ca

Abiomed, Inc.

DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-S

Katalyst Surgical, LLC

Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and du

Aizu Olympus Co., Ltd.

Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue

Olympus Corporation of the Americas

Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583] T

TERRAGENE S.A.

Medline medical procedure kits labeled as follows: DENTAL, REF DYNJ909211A

MEDLINE INDUSTRIES, LP - Northfield

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGI

MEDLINE INDUSTRIES, LP - Northfield

Infusomat UNIV 60 DROP PUMP SET, W/2 CARESITE INJ. -Used with an electrically-powered infusion pump for intravenous (IV)

B. Braun Medical, Inc.

Medline convenience kits: C SECTION CDS985505G C SECTION PACK DYNJ68260D C-SECTION DYNJ905094B C-SECTION

Medline Industries, LP

Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scisso

Intuitive Surgical, Inc.

Cervical Tray Catalog 1089

Busse Hospital Disposables, Inc.

Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN:

Siemens Healthcare Diagnostics, Inc.

MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin p

Medtronic MiniMed, Inc.

Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) Recommend

ev3 Inc.

Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary drainage from the bladder of a

Cardinal Health

Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (

C-RAD POSITIONING AB

A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit

Windstone Medical Packaging, Inc.

Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catal

Randox Laboratories, Limited

Halyard ENT T AND A PACK - Medical convenience kits Model Number: EAMC106-02

AVID Medical, Inc.

GEO-MED TOTAL KNEE PACK A & B, REF 89-6799.02

DeRoyal Industries Inc

API 50 CH, Model 50300

bioMerieux, Inc.

ACL PACK - 206039-Procedure Kit Catalog Number: UDAC66AA

American Contract Systems Inc