BEUDAMED
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    Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001)) The SPY Fluorescent Imaging System is intended to provide fluorescent images for the visual assessment of blood flow in vessels and related tissue perfusion during cardiovascular surgical procedures. For use in intraoperative visual assessment of the coronary vasculature and bypass grafts during coronary artery bypass (BABG) surgery.

    FDA Recall
    Terminated ·NOVADAQ TECHNOLOGIES INC.·Product code IZI·August 18, 2016

    PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motorized device automatically compresses a resuscitator bag to provide air to the lungs of a COVID-19 patient, eliminating the human error and fatigue that results from manual actuation. PREVENT is indicated for emergency resuscitation with appropriate patient monitoring on adult patients that require mechanical respiratory support.

    FDA Recall
    Open, Classified ·Precision Valve & Automation, Inc·Product code BTL·June 26, 2020

    Cook Polyvinyl Alcohol Foam (PVA ) Embolization Particles, particle size 47-90 microns, 1 cc; order number PVA-50.

    FDA Recall
    Terminated ·Cook, Inc.·July 1, 2003

    Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 180-300 microns, 1 cc; order number PVA-200.

    FDA Recall
    Terminated ·Cook, Inc.·July 1, 2003

    Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 710-1000 microns, 1 cc; order number PVA-700.

    FDA Recall
    Terminated ·Cook, Inc.·July 1, 2003

    Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 300-500 microns, 1 cc; order number PVA-300.

    FDA Recall
    Terminated ·Cook, Inc.·July 1, 2003

    Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 500-710 microns, 1 cc; order number PVA-500.

    FDA Recall
    Terminated ·Cook, Inc.·July 1, 2003

    Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 90-180 microns, 1 cc; order number PVA-100.

    FDA Recall
    Terminated ·Cook, Inc.·July 1, 2003

    Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height Parallel Sterile is a stand alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1.

    FDA Recall
    Terminated ·Synthes USA HQ, Inc.·Product code OVE·September 30, 2013

    Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012

    FDA Recall
    Open, Classified ·Meridian Bioscience Inc·Product code IGG·October 19, 2023

    Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312

    FDA Recall
    Open, Classified ·Meridian Bioscience Inc·Product code FMH·October 19, 2023

    Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: CHB900312

    FDA Recall
    Open, Classified ·Meridian Bioscience Inc·Product code FMH·October 19, 2023

    PVA Foam Surgical Spears Catalog #: OASIS0525

    FDA Recall
    Terminated ·Ultracell Medical Technologies·Product code HOZ·January 8, 2003

    Lasik Custom Pak containing 1 dual tip irrigator, 8 ports, 16 G, 2 packs spears, eye, ocucel, 5S, PVA, 1 cover, support, tray 2.2MIL 6FD, and 2 dressings, tegaderm, 2 3/8 x 2 3/4. All contents considered sterile unless package is opened or damaged.RX Only. Part number 10162-01. (The Vidaurri LASIK Flap Irrigators are included in the firm''s Alcon Custom Pak Part Number 10162-01 under the description of dual tip irrigator, 8 ports, 16G.)

    FDA Recall
    Terminated ·Alcon Research, Ltd·Product code LQJ·September 2, 2005

    Total Knee Pack, REF CETJ130, medical convenience kits

    FDA Recall
    Open, Classified ·American Contract Systems, Inc.·Product code OJH·April 17, 2023

    Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E ENFit" SALEM SUMP" PVC TUBE 12FR 48IN 8888264945E ENFit" SALEM SUMP" PVC TUBE 14FR 48IN 8888264960E ENFit" Salem Sump" PVC Tube 16Fr 48IN 8888264986E ENFit" SALEM SUMP" PVC TUBE 18FR 48IN 8888266106E PVC SALEM SUMP WITH ENFIT & ARV 10FR 36IN 8888266114E PVC SALEM SUMP WITH ENFIT & ARV 12FR 48IN 8888266122E PVC SALEM SUMP WITH ENFIT & ARV 14FR 48IN 8888266130E PVC SALEM SUMP WITH ENFIT & ARV 16FR 48IN 8888266148E PVC SALEM SUMP WITH ENFIT & ARV 18FR 48IN 8888268060E ENFit" SALEM SUMP" PVC TUBE 6FR 24IN 8888268086E ENFit" Salem Sump" PVC Tube 8Fr 24IN

    FDA Recall
    Open, Classified ·Cardinal Health 200, LLC·Product code FEG·September 18, 2025

    The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the ligaments of the vaginal cavity. The anchors are pre-loaded inside the device shaft and are ready for use. A thimble is also supplied, as an accessory for the device, to be used as a guide channel for better handling of the EnPlace. Intended Use / Indications for Use: The EnPlace system is intended for attaching sutures to ligaments of the pelvic floor.

    FDA Recall
    Open, Classified ·FEMSelect Ltd HaMa'ayan 2 First Floor Modi'in Israel·Product code PBQ·December 13, 2021

    Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319, SpectrumOrange/ 13q34, SpectrumAqua/CEP 12 SpectrumGreen Probes

    FDA Recall
    Terminated ·Abbott Molecular, Inc.·Product code OVQ·August 4, 2021

    GENE-UP REAGENT GENE-UP LYSIS KIT, CATALOG 414057

    FDA Recall
    Open, Classified ·Biomerieux Inc·Product code NVQ·November 9, 2022

    Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x 90 cm 1180264416 Salem Sump" PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 114 cm 1180264424 Salem Sump" PVC Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm 1180264432 Salem Sump" PVC Gastroduodenal Tube, 16 Fr/Ch (5.3 mm) x 114 cm 1180264440 Salem Sump" PVC Gastroduodenal Tube, 18 Fr/Ch (6.0 mm) x 114 cm 1180264457 Salem Sump" PVC Gastroduodenal Tube, 20 Fr/Ch (6.7 mm) x 114 cm 1180264523 Salem Sump" Polyurethane Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm 1180264531 Salem Sump" Polyurethane Gastroduodenal Tube, 16 Fr/Ch (5.3 mm) x 114 cm 1180264549 Salem Sump" Polyurethane Gastroduodenal Tube, 18 Fr/Ch (6.0 mm) x 114 cm 1180264556 Salem Sump" Polyurethane Gastroduodenal Tube, 20 Fr/Ch (6.7 mm) x 114 cm 1180264895 Salem Sump PVC Gastroduodenal Tube, 20 Fr/Ch (3.3mm), 108 cm 8888264804 Salem Sump PVC Gastroduodenal Tube, 10Fr/Ch (3.3 mm) x 85 cm 8888264820 Salem Sump PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 108 cm 8888264846 Salem Sump PVC Gastroduodenal Tube, 14 Fr/Ch (4.7mm), 108 cm 8888264861 Salem Sump PVC Gastroduodenal Tube, 16 Fr/Ch (5.3mm), 108 cm 8888264887 Salem Sump PVC Gastroduodenal Tube, 18 Fr/Ch (6.0mm), 108 cm SKUs not distributed in US

    FDA Recall
    Open, Classified ·Cardinal Health 200, LLC·Product code FEG·September 18, 2025