38 results · 12ms · Sources: EU EUDAMED, US FDA

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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

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

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

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

FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827

FDA Recall
Open, Classified ·O & M HALYARD, INC.·Product code MSH·August 9, 2023

Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.

FDA Recall
Open, Classified ·Atrium Medical Corporation·Product code GBZ·September 29, 2023

Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF SU130-4601

FDA Recall
Open, Classified ·Cardinal Health 200, LLC·Product code GBX·March 27, 2024

Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code CAE·March 9, 2022

Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 15Fr., REF SU130-403D

FDA Recall
Open, Classified ·Cardinal Health 200, LLC·Product code GBX·March 27, 2024

Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401D

FDA Recall
Open, Classified ·Cardinal Health 200, LLC·Product code GBX·March 27, 2024

Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr., REF SU130-402D

FDA Recall
Open, Classified ·Cardinal Health 200, LLC·Product code GBX·March 27, 2024

Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marked 8888266197 Salem Sump" Anti-Reflux Valve

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

Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum. Product REF Number: 15028

FDA Recall
Open, Classified ·Atrium Medical Corporation·Product code GBZ·April 21, 2022

Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.

FDA Recall
Open, Classified ·Windstone Medical Packaging, Inc.·Product code LRO·August 16, 2024

Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.

FDA Recall
Open, Classified ·Windstone Medical Packaging, Inc.·Product code LRO·August 16, 2024