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FDA Medical Device Recalls

View 10000 FDA Medical Device Recalls on BEUDAMED, the Better Database on Medical Devices. This searchable listing aggregates recall notices issued by the U.S. Food and Drug Administration for devices removed, corrected, or returned due to safety, labeling, or performance concerns. Each record summarizes the recall reason, affected models and lots, recall class, and recommended actions for patients and providers.

Searchable filters help stakeholders identify affected manufacturers, device models, and recall classes (Class I–III) and review timelines and remediation steps. Healthcare providers and purchasers can use these records to verify whether inventory is affected and to implement recommended corrections, returns, or patient notifications.

Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.

FDA Recall
Terminated ·Luminex Corporation·Product code PCH·May 8, 2018

Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D

FDA Recall
Terminated ·GE Healthcare, LLC·Product code IYN·July 2, 2019

Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294, 10015414, 10933805, 11171447, 11404930, 11522558, 11607704, 10013361T, 2110-0500, 2126-0500, 2200-0500, 2411-0500, 2419-0007, 2420-0007, 2420-0500, 2421-0500, 2426-0007, 2426-0500, 2429-0500, 2433-0007, 2477-0000, 2477-0007 2478-0000 C24116E Infusion sets allow for the intravenous administration of fluids, medications, nutritional support and transfusion therapy through a needle or catheter inserted into the patient s artery or vein.

FDA Recall
Terminated ·Becton Dickinson & Company·Product code FPA·May 6, 2019

Giraffe Infant Radiant Warmer 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
Terminated ·GE Healthcare, LLC·Product code FMT·March 15, 2019

ElectroMist product codes: 36-3310-04 - Product Usage: Electrode Conductivity Spray Solution.

FDA Recall
Terminated ·Pharmaceutical Innovations, Inc.·Product code GYB·June 19, 2019

AXIOM Artis dFC, Model Number 7412807

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019

Terumo Needle, 30G x 1/2", Product Code NN3013R

FDA Recall
Terminated ·Terumo Medical Corporation·Product code FMI·February 8, 2019

Monoject Blunt Cannula, 22 G x 1-1/2" (0.711 mm x 3.8 cm) Item code: 8881202389

FDA Recall
Completed ·Cardinal Health·Product code FMI·April 30, 2019

Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code: B2-70072-F

FDA Recall
Terminated ·Zyno Medical LLC·Product code FPA·May 29, 2019

AXIOM Artis dTC, Model Number 7413078

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019