Medical Device Recalls

Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system

SEDECAL SA

Univation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL COMP.T1 RM/LM 7MM; N

Aesculap Implant Systems LLC

Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;

Gentuity, LLC

Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)

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

HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology.

Stradis Healthcare

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

B Braun Medical Inc

DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457

Beckman Coulter, Inc.

MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the v

Angiodynamics, Inc.

MEDLINE Kits, trays, and packs labeled as follows: a) ASC GENERAL MINOR CDS, REF CDS983673G; b) ASC GENERAL MINOR C

MEDLINE INDUSTRIES, LP - Northfield

NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2

Medtronic Xomed, Inc.

Philips Azurion system; Software Version Number: R3.1;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Cascade IOMAX Cortical Module, REF: 190296-200

Cadwell Industries Inc

Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM M

Merit Medical Systems, Inc.

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

B Braun Medical Inc

Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Number CDS984642, b. VASCULAR CDS, Model Number

MEDLINE INDUSTRIES, LP - SPT

Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF

Abbott Molecular, Inc.

HPV Antigen Test

GET TESTED INTERNATIONAL AB

Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197

Stryker Corporation

50-GEL20; Ultrasound gel

Advance Medical Designs, Inc.

RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548

Cardinal Health

Medline Convenience kits labeled as: 1) LABOR & DELIVERY CDS, Pack Number CDS830039AD; 2) FETAL SURGERY CDS-LF, Pack

MEDLINE INDUSTRIES, LP - Northfield

Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014

Medtronic Perfusion Systems

human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.

HUMAN MED AG

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000192;

Beaver Visitec International, Inc.

Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only

Karl Storz Endoscopy

Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C; Software Version: NA Product Descrip

ZOLL Medical Corporation

FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding

I.T.S. GmbH

LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577

Physio-Control, Inc.

ICD-VR VISIA AF S US/OUS IS1/DF1, Model Number DVAC3D1; Implantable Cardioverter Defibrillators

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

Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control se

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