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Medical Device Safety

Update – November 21, 2024

CDRH is announcing a communications pilot to enhance the medical device recall program and to improve the timeliness of communications about corrective actions being taken by companies that the FDA believes are likely to be high-risk recalls. The pilot will include early alerts of potentially high-risk device removals or corrections related to cardiovascular, gastrorenal, general hospital, obstetrics and gynecology, and urology. This pilot follows the commitments noted in our 2024 Safety Report and recommendations from the Patient Engagement Advisory Committee, to enhance our medical device recall program.

The FDA monitors reports of adverse events and other problems with medical devices and when needed, alerts patients, health care providers, industry, and the public. The lists below contain our most recent information. For additional information, contact us – Division of Industry and Consumer Education (DICE).


Recent Medical Device Safety Communications

The FDA's analyses and recommendations for patients and health care providers about ongoing medical device safety issues.

Recent Medical Device Recalls and Early Alerts

Medical device recalls that may potentially present significant risks. Note that Early Alerts, as part of a pilot, include information on actions being taken by companies that the FDA believes are likely to be the most serious type of recall, but where the FDA may not yet have determined that the actions meet the regulatory definition of a recall. These actions may include when companies remove products from the market, correct products, or update instructions for using products due to potentially high safety risks.

Device Name Publish Date
Blood Products Administration Set Recall: Fresenius Kabi Removes Large Volume Pump Blood Products Administration Sets due to Incorrect Assembly
Convenience Kit Recall: Medline Industries, LP, Removes Medline Neonatal and Pediatric Kits containing Smiths Medical ORAL/NASAL Endotracheal Tubes Due to Smaller Than Expected Tube Diameter That May Cause Underventilation
Aspiration Catheter Recall: Q’Apel Medical, Inc. Removes Hippo 072 Aspiration System and Cheetah Delivery Tool After FDA Warning Letter About Internal Processes and Distal Tip Characteristics
Infusion Pump Recall: Zyno Medical Removes Certain Z-800 Series Infusion Pumps due to Software Issue
Intra-Operative Positioning System Guidewire Recall: Centerline Biomedical Removes Certain IOPS Guidewires due to Delamination
Liquid Bicarbonate Concentrate Recall: Nipro Removes MedicaLyte Liquid Bicarbonate Concentrate due to Contamination
Flexible Tracheostomy Tube Recall: Medtronic Removes Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula Due to Risk for Disconnection of the Flange from the Device Cannula
Anesthesia Breathing Circuit Kit Correction: Draeger, Inc. Updates Use Instructions for VentStar Flex and Anesthesia Circuit Kits Due to Cracks in Hose That May Cause Inadequate Ventilation
Infusion Pump Correction: Baxter Updates Instructions for Use for Novum IQ Large Volume Pump due to Potential for Underinfusion
Infusion Pump Recall: False Alarm Issue with Infusion Pump from Smiths Medical
Infusion Pump Recall: Infusion Pump Intermittent Connection Issue from Smiths Medical
Infusion Pump Recall: Infusion Pump Thermal Damage Issue from Smiths Medical
Esophagogastric Tube Recall: BD Issues Correction for Esophagogastric Balloon Tamponade Tubes due to Challenges Removing Plastic Plugs from Rubber Lumen
Heart Pump Accessory Removal: Abbott Removes HeartMate Mobile Power Unit due to Instances of Sudden Power Loss
Early Alert: Intravascular PICC Catheter Issue from BD
Early Alert: Diagnostic Intravascular Catheter Issue from Conavi
Vascular Cannula Recall: Medtronic Removes Aortic Root Cannula Due to Unexpected Loose Material in the Male Luer
Endotracheal Tube Recall: Smiths Medical Removes Intubation ORAL/NASAL Endotracheal Tubes Due to Smaller Than Expected Tube Diameter That May Cause Underventilation

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