Medical Devices Recalls

Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967

Preat Corp

MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system. …

Angiodynamics, Inc.

Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1

Covidien

I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175

In2Bones, SAS

NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regul…

Mc3 Inc

Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023070S

Sarnova HC, Llc

MINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Ca…

Angiodynamics, Inc.

Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090

Medtronic Inc.

MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. - C…

Angiodynamics, Inc.

MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. …

Angiodynamics, Inc.

Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm)

D.O.R.C. Dutch Opthalmic Research Center Intl B.V.

FDA Devices Critical Mar 27, 2024

Abbott Point of Care Control Control i-STAT¿ Level 1 10 X 1.7 mL

Mckesson Medical-Surgical Inc. Corporate Office

ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-04220; b) REF ASK-04220-FMH1; c) REF ASK-04220-H…

ARROW INTERNATIONAL Inc.

LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004

Fresenius Kabi USA, LLC

SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented

Waldemar Link GmbH & Co. KG (Mfg Site)

BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation of the eye Catalog Number: 581012

Beaver Visitec International, Inc.

LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004

Fresenius Kabi USA, LLC

L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Sterile

Peter Lazic Gmbh

CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401

Baxter Healthcare Corporation

FDA Devices Critical Mar 20, 2024

CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibility and…

Biosense Webster, Inc.

CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single-use

Medos International Sarl

Atellica IM Erythropoietin (EPO) Assay (100 Test)

Siemens Healthcare Diagnostics, Inc.

SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented

Waldemar Link GmbH & Co. KG (Mfg Site)

D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action.

Peter Lazic Gmbh

EasyPoint Needle, 25G x 5/8", REF: 82091

Retractable Technologies, Inc.

D-Clip Standard/Mini Applier, 210mm bayonet, jaw rigid, double action.

Peter Lazic Gmbh

SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented

Waldemar Link GmbH & Co. KG (Mfg Site)

Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S

Synthes (USA) Products LLC

Synapse PACS - Version 7.2.100

FUJIFILM Healthcare Americas Corporation

RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (…

Synthes (USA) Products LLC

Synapse PACS - Version 7.1.000

FUJIFILM Healthcare Americas Corporation

ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.

ConvaTec, Inc

13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle de…

Synthes (USA) Products LLC

BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352;

CareFusion 303, Inc.

VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)

Ortho-Clinical Diagnostics, Inc.

Synapse PACS - Version 7.2.000

FUJIFILM Healthcare Americas Corporation

Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model Numbers: (1) G50 (2) G53 (3) G54 (4) BAR5490IVC (5) BAR5000…

Invacare Corporation

DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic procedures.

Aesculap Inc

NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM

Howmedica Osteonics Corp.

Synapse PACS - Version 7.1.000US

FUJIFILM Healthcare Americas Corporation

VITROS XT 7600 Integrated System, Catalog No. 6844461

Ortho-Clinical Diagnostics, Inc.

DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic procedures.

Aesculap Inc

Embrace Drill Tower, Wedged (25mm)

Waldemar Link GmbH & Co. KG (Mfg Site)

X3 TRIATHLON CS INSERT NO 6 10 MM

Howmedica Osteonics Corp.

VITROS 5600 Integrated System (New and Refurbished)

Ortho-Clinical Diagnostics, Inc.

FDA Devices Critical Mar 13, 2024

TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944S

Synthes (USA) Products LLC

MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic P…

Avanos Medical, Inc.

MRI system: Vantage Elan, Model: MRT-2020

Canon Medical System, USA, INC.

DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures.

Aesculap Inc