Medical Device Recalls

Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5 User Manual: ACTIV5 USER MANUAL Welcome to Activ5, the

Activbody, Inc.

LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellet

Microbiologics Inc

Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754)

Medtronic MiniMed, Inc.

MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results

BioMerieux SA

3.2MM Pellet Insertion Tray Catalog Number: B9743

Busse Hospital Disposables, Inc.

Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02

CELLTRION USA INC

ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5

ICU Medical, Inc.

Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Lock LOR Tray (Kit) A collection of device

B. Braun Medical, Inc.

BIOBALL B.SPIZIZENII NCTC 10400 550X20, CATALOG 56012

Biomerieux Inc

Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor

SUREPULSE MEDICAL LTD

Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060

Boston Scientific Corporation

CRT-D DTBC2QQ BRAVA QUAD IS4/DF4 INTL, Model Number DTBC2QQ; Implantable Cardioverter Defibrillators

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

ADVANTA VXT, 6X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960;

Sklar Instruments

Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical

Agfa Healthcare NV

Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900C

Medtronic Neuromodulation

8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006

Intuitive Surgical, Inc.

Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000

Landauer

MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)

Medtronic MiniMed, Inc.

Medline procedure kits labeled as: 1) LACERATION TRAY, Pack Number DYNJ17328B

MEDLINE INDUSTRIES, LP - Northfield

Blood Pump Rotor, Model Number: F40015481 Rev A

Fresenius Medical Care Holdings, Inc.

VITEK 2 Systems and VITEK 2 with MYLA.

bioMerieux, Inc.

Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of int

Beckman Coulter, Inc.

Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.

Fisher Diagnostics

Medline procedural kits labeled as: 1) OPEN HEART PEDS, Pack Number CDS981050Q; 2) OPEN HEART CDS, Pack Number CDS9

MEDLINE INDUSTRIES, LP - Northfield

Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use

Erbe USA Inc

Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; 2) ANGIO PACK, Model Number: DYNJT2021G; 3) ANGIOGR

Medline Industries, LP

DeRoyal SHOULDER PACK, REF 89-9449.13

DeRoyal Industries Inc

HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002

Access Vascular, Inc

GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"

GE Healthcare, LLC