Medical Device Recalls

48" Lead Wires, Replacement Part Number: 1067724-4

EBI, LLC

QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecu

Qiagen Sciences LLC

TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E

Howmedica Osteonics Corp.

HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Produc

Philips North America Llc

TEMPO REAGENTS TEMPO CONTROL KIT , CATALOG 80000

Biomerieux Inc

KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K

Microbiologics Inc

SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200

Stryker Corporation

Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surg

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers with syng

Siemens Medical Solutions USA, Inc

Change Healthcare Radiology Solutions software version 14.2.2

CHANGE HEALTHCARE CANADA COMPANY

Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and il

Aizu Olympus Co., Ltd.

nanoDot D2DNN, Model Numbers: a) 18105-000; b) 18105-KIT; radiation monitoring dosimeter used with the microSTAR re

Landauer

navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material

Ventana Medical Systems, Inc.

Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality

Surgical Theater Inc

Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434

Medicalplastic S.R.L.

Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-200-005

Stryker Corporation

Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, (3) G5S-10C, (4) G5S-

ZOLL Medical Corporation

HENRY SCHEIN, EXTREMITY PACK, Item No.570-2946

Stradis Medical, LLC dba Stradis Healthcare

Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU 75CM CV327DA 88862880-41 TICR

Covidien, LP

Medline procedural kits labeled as: 1) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 2) NICU CIRCUMCISION TRAY W/

MEDLINE INDUSTRIES, LP - Northfield

Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN

Getinge Usa Sales Inc

Aisys CS2. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to p

Datex-Ohmeda, Inc.

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PROBE COVER PACK, Model Number

MEDLINE INDUSTRIES, LP - Northfield

RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480035

TELEFLEX LLC

KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)

Microbiologics Inc

Nerve Block Tray Catalog Number: 3764R2

Busse Hospital Disposables, Inc.

Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Syste

Medline Industries, LP

The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da Vinci Xi and

Intuitive Surgical, Inc.

Cardinal Health Presource Kits: 1) CRANIOTOMY PACK, Catalog Number: 2NE69CNK12; 2) CHI STD NEURO CRANI OPT 4, Catalog

Cardinal Health 200, LLC

IV Sets with drip chambers

ICU Medical, Inc.