BEUDAMED
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    Bodor P and C series laser cutting machines

    FDA Recall
    Open, Classified ·Jinan Bodor Cnc Machine Co Ltd NO.1299, XINLUO AVE HI-TECH ZONE Jinan China·Product code RFE·December 19, 2024

    Bodor's I series laser cutting machine.

    FDA Recall
    Open, Classified ·Jinan Bodor Cnc Machine Co Ltd NO.1299, XINLUO AVE HI-TECH ZONE Jinan China·Product code RFE·February 7, 2025

    Material Processing Laser Products

    FDA Recall
    Open, Classified ·SHENZHEN ATOMSTACK TECHNOLOGIES·Product code RFE·September 30, 2025

    Maquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E - ARD568131211C, G8G8 DF E - ARD568121111C, G8G8FS DF - ARD568121131C

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code FSY·November 8, 2023

    AFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7220 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.

    FDA Recall
    Open, Classified ·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·Product code JKA·September 26, 2025

    Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Applicable Product Description: Lumipulse G pTau217/-Amyloid 1-42 Plasma Ratio is an in vitro diagnostic (IVD) test that combines the test results of the Lumipulse G pTau 217 Plasma assay and the Lumipulse G -Amyloid 1-42-N Plasma assay from the same patient specimen (K2EDTA plasma sample) into a numerical ratio. The Lumipulse G pTau 217/-Amyloid 1-42 Plasma Ratio Instructions For Use (IFU), CL0072, contains instructions on how to manually calculate the ratio and is supplied with each individual Lumipulse G assay. Lumipulse G pTau217/-Amyloid 1-42 Plasma Ratio, Item# CL0073 is comprised of the following kits, which are imported: Kit Description, Item#: Imported from Fujirebio Europe (FRE): Lumipulse G pTau 217 Plasma Immunoreaction Cartridges 81550 Lumipulse G pTau 217 Plasma Calibrators set 81557 Lumipulse pTau 217 Plasma Controls 81558 Lumipulse -Amyloid Plasma Controls 81559 Imported from Fujirebio Japan (FRI): Lumipulse G -Amyloid 1-42-N Plasma Immunoreaction Cartridges 235447 Lumipulse G -Amyloid 1-42-N Plasma Calibrators set 235454 Component: No

    FDA Recall
    Open, Classified ·Fujirebio Diagnostics, Inc.·Product code SET·December 11, 2025

    The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the Onyx liquid embolic system (LES). The catheter has a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The proximal end of the catheter incorporates a standard Luer adapter to facilitate the attachment of accessories. The outer diameter surface of the catheter is hydrophilically coated to increase lubricity. The AOMC is designed to facilitate catheter retrieval in the event the catheter becomes entrapped within the vasculature. The distal section of the catheter incorporates a detachment zone that allows detachment of the distal tip when the force required to extract the catheter exceeds the force to detach the tip. The catheter has two radiopaque marker bands to visualize the position of the catheter and the detach zone area, one proximal to the detach zone and one at the distal end of the catheter.

    FDA Recall
    Open, Classified ·Micro Therapeutics, Inc.·Product code MFE·January 11, 2024

    The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the Onyx liquid embolic system (LES). The catheter has a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The proximal end of the catheter incorporates a standard Luer adapter to facilitate the attachment of accessories. The outer diameter surface of the catheter is hydrophilically coated to increase lubricity. The AOMC is designed to facilitate catheter retrieval in the event the catheter becomes entrapped within the vasculature. The distal section of the catheter incorporates a detachment zone that allows detachment of the distal tip when the force required to extract the catheter exceeds the force to detach the tip. The catheter has two radiopaque marker bands to visualize the position of the catheter and the detach zone area, one proximal to the detach zone and one at the distal end of the catheter.

    FDA Recall
    Open, Classified ·Micro Therapeutics, Inc.·Product code MFE·January 11, 2024

    The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor

    FDA Recall
    Open, Classified ·Sophysa Rue Sophie Germain Besancon France·Product code GWM·November 17, 2025

    Brand Name: Elegance Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LEVEL CERVICAL PLATE, ELEGANCE 4 LEVEL CERVICAL PLATE Model/Catalog Number: See Excel sheet attached named "FDA 5072 Product Information" Software Version: Not applicable Product Description: The EleganceAnterior Cervical plate is designed for use as a cervical plate system. It has a shape which restores the intervertebral height and lordosis. The Elegance Anterior Cervical plate consists in a variety of shapes and sizes of cervical plates with rounded corners, featuring bone screw s holes, locking systems and bone screws. The plates go from one (1) to five (5) levels, and the screws are selfdrilling or self- tapping, and fixed or variable. The fixation is provided by the bone screws inserted into the vertebral body by means of an anterior approach. The Eleganceplates, as well as the bone screws, are made of compliant ASTM F136 Titanium alloy. It is essential to insert the implants with the instrumentation specifically designed for this purpose. For more description of the instrumentation, read the technical documentation associated to the Elegance Anterior Cervical plate. Detailed information concerning the surgical technique of the EleganceAnterior Cervical plate is available upon request, please contact CLARIANCE or its local representative.

    FDA Recall
    Open, Classified ·Clariance-SAS 18 Rue Robespierre Beaurains France·Product code KWQ·February 20, 2026

    stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

    FDA Recall
    Open, Classified ·Tornier S.A.S. 161 Rue Lavoisier Montbonnot-Saint-Martin France·Product code OLO·March 5, 2025

    stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

    FDA Recall
    Open, Classified ·Tornier S.A.S. 161 Rue Lavoisier Montbonnot-Saint-Martin France·Product code OLO·March 5, 2025

    Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.

    FDA Recall
    Open, Classified ·Tornier S.A.S. 161 Rue Lavoisier Montbonnot-Saint-Martin France·Product code OLO·December 18, 2024

    stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

    FDA Recall
    Open, Classified ·Tornier S.A.S. 161 Rue Lavoisier Montbonnot-Saint-Martin France·Product code OLO·March 5, 2025

    stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty

    FDA Recall
    Open, Classified ·Tornier S.A.S. 161 Rue Lavoisier Montbonnot-Saint-Martin France·Product code OLO·March 5, 2025

    Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.

    FDA Recall
    Open, Classified ·Tornier S.A.S. 161 Rue Lavoisier Montbonnot-Saint-Martin France·Product code PHX·April 10, 2025

    stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

    FDA Recall
    Open, Classified ·Tornier S.A.S. 161 Rue Lavoisier Montbonnot-Saint-Martin France·Product code OLO·March 5, 2025

    stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

    FDA Recall
    Open, Classified ·Tornier S.A.S. 161 Rue Lavoisier Montbonnot-Saint-Martin France·Product code OLO·March 5, 2025

    stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder Arthroplasty

    FDA Recall
    Open, Classified ·Tornier S.A.S. 161 Rue Lavoisier Montbonnot-Saint-Martin France·Product code OLO·March 5, 2025

    stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

    FDA Recall
    Open, Classified ·Tornier S.A.S. 161 Rue Lavoisier Montbonnot-Saint-Martin France·Product code OLO·March 5, 2025