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    VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR) Product Number: 174-0012

    FDA Recall
    Open, Classified ·Visionsense, Ltd. 20, Ha-Magshimim Petakh Tikva Israel·Product code OWN·October 17, 2022

    VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Combiner) Product Number: 161-0001

    FDA Recall
    Open, Classified ·Visionsense, Ltd. 20, Ha-Magshimim Petakh Tikva Israel·Product code OWN·October 17, 2022

    VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm Product Number: 175-0012

    FDA Recall
    Open, Classified ·Visionsense, Ltd. 20, Ha-Magshimim Petakh Tikva Israel·Product code OWN·October 17, 2022

    Quest Spectrum 3 Fluorescent Imaging System Model/Catalog Number: ART-SYS-0029, ART-SYS-0030 The Quest Spectrum3 is a fluorescent imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used during plastic and reconstructive surgeries.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code OWN·September 24, 2024

    GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment.

    FDA Recall
    Open, Classified ·Wipro GE Healthcare Private Ltd. 122 Part 1 Odyssey And Galileo Bengaluru India·Product code FMT·August 9, 2024

    Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo regulate based on their own physiology.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code FMZ·July 26, 2019

    Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme.

    FDA Recall
    Open, Classified ·Parker Laboratories, Inc.·Product code GYB·March 22, 2024

    OMTech Desktop Laser Engraver

    FDA Recall
    Open, Classified ·Rygel Advanced Machines d/b/a Omtech Laser·Product code RIM·June 7, 2024

    MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use Gown; Sold in kit with Sterile Gown/Hand Towel/CSR Wrap and boxes of 18 Gowns.

    FDA Recall
    Open, Classified ·Product code FYA·June 1, 2017

    My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device

    FDA Recall
    Open, Classified ·Onkos Surgical, Inc.·Product code QHQ·May 20, 2025

    The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which includes its own battery power supply. The measured LED positions can be used in one of three different modes of operation: Patient tracking, Registration using surface matching, and Automatic intra-operative mask registration.

    FDA Recall
    Open, Classified ·Howmedica Osteonics Corp.·Product code HAW·November 12, 2025

    The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg Extension Stent-Graft, a Proximal Cuff Stent-Graft and a Straight Iliac Extension Stent-Graft. Each stent-graft is preloaded into its own delivery system that is advanced under fluoroscopy to the location of the infrarenal aneurysm. The stent-graft is deployed at the intended location and creates a blood flow channel, excluding the aneurysm from blood pressure and flow.

    FDA Recall
    Open, Classified ·Bolton Medical Inc.·Product code MIH·May 3, 2023

    AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-0970-1 Vivonic Part Number: G02000966-US

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code FIP·June 21, 2022

    AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-10VA-1 Vivonic Part Number: G02000970-US

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code FIP·June 21, 2022

    A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Open Interbody 32x24x12 7 A Link Z Ti Unitary Open Interbody 32x24x12 12 A Link Z Ti Unitary Open Interbody 32x24x16 7 A Link Z Ti Unitary Open Interbody 32x24x16 12 Product Usage: is a spinal device that is implanted in the intervertebral body space via an anterior approach to improve stability of the spine while supporting fusion.

    FDA Recall
    Open, Classified ·Acuity Surgical Devices, LLC·Product code OVD·January 7, 2019

    Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010

    FDA Recall
    Open, Classified ·Healthmark Industries Co., Inc.·Product code MNL·May 2, 2025

    ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)

    FDA Recall
    Open, Classified ·Healthmark Industries Co., Inc.·Product code MNL·May 2, 2025

    CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant Product Usage: The CMI device, Ivy Sports Medicine s collagen-based meniscus implant, is comprised primarily of bovine type I collagen (nominally 99%) derived from tendon and small quantities of glycosaminoglycans (GAGs: chondroitin sulfate and sodium hyaluronate). The device functions as a resorbable scaffold that is replaced by the patient s own tissue.The CMI device is designed to function as an absorbable template to facilitate host meniscus tissue regeneration in patients who have an irreparable meniscus tear or loss of meniscus tissue. The CMI meniscus tissue through the implant s absorption and replacement by patient s native tissue.

    FDA Recall
    Open, Classified ·Stryker Corporation·Product code OLC·January 25, 2018

    CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures Product Numbers: (1) ROB10000 CORI Starter Kit (2) ROB10024 Real Intelligence CORI (3) ROB10197 CORI STARTER KIT - UNIVERSAL Note: the three product numbers cover the three different configurations in which the CORI Console is sold

    FDA Recall
    Open, Classified ·Blue Belt Technologies, Inc·Product code OLO·May 7, 2024

    Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322, spinal implant

    FDA Recall
    Open, Classified ·Medtronic Sofamor Danek USA Inc·Product code OVD·June 6, 2023