+1 (319) 433-6210

Medical Device Safety Alerts

Consumer-oriented medical device information

Medical Device Safety Alerts

The Food and Drug Administration (FDA) routinely publishes a variety of alerts related to the safety of medical devices.

The agency receives complaints and other safety-related information from health care providers, manufacturers, and consumers on its MedWatch program.

When the FDA deems it to be appropriate based on the severity of the issue, the volume of complaints, or other factors, it will issue a warning or safety alert to health care providers and the public.

Warnings and safety alerts can include:

  • Product issues.
  • Ancillary issues that can be a safety hazard, such as labeling.
  • Recalls.
  • Any other information related to a negative effect on the safety of a product.

Fresenius Kabi Recalls Ivenix Infusion Pump Software 

Apr 17, 2024

Urgent Class I Recall Notice   A crucial recall notice has been issued by Fresenius Kabi USA, LLC for the LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0, distributed between March 6, 2023, and March 20, 2024. The recall, initiated on March 7, 2024, is...

read more

Medical Device FDA Safety Alerts

DateSubjectProduct areaMore information
03/19/2024Update: Evaluating Plastic Syringes Made in China for Potential Device FailuresSyringesSafety Communication
02/29/2024Hintermann Series H3 Total Ankle Replacement Has a Higher-Than-Expected Risk of Device FailureJoint ReplacementSafety Communication
02/27/2024BioZorb Markers and Potential Risks with Use in Breast TissueBreast TissueSafety Communication
02/21/2024Do Not Use Smartwatches or Smart Rings to Measure Blood Glucose LevelsBlood GlucoseSafety Communication
02/02/2024Do Not Use Certain Cardinal Health Monoject Luer-Lock and Enteral SyringesSyringesSafety Communication
01/18/2024Certain ResMed Ltd Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical DevicesBiPAP, CPAP MachinesSafety Communication
01/16/2024Risks with Exactech Equinoxe Shoulder System with Defective PackagingJoint ReplacementSafety Communication
01/03/2024Do Not Use Synovo Total Hip Resurfacing SystemImplantsSafety Communication
11/30/2023Evaluating Plastic Syringes Made in China for Potential Device FailuresSyringesSafety Communication
11/28/2023Carefully Monitor Philips DreamStation 2 CPAP Machines for Signs of OverheatingCPAP MachineSafety Communication
11/21/2023Voluntary Recall of SoClean Equipment Intended for Use with CPAP Devices and AccessoriesCleanerSafety Communication
11/06/2023Recall of Certain Saline and Sterile Water Medical Products Associated with Nurse AssistSaline, Sterile Water Medical ProductsSafety Communication
09/29/2023Update: Recommendations for Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face MasksSurgical N95 respirators, surgical masks,
pediatric face masks		Safety Communication
08/11/2023Do Not Use Tests Manufactured by Universal Meditech, Inc.In Vitro DiagnosticsSafety Communication
07/17/2023Do Not Use RoyalVibe Health, CellQuicken, or Well-Being Reality Ultrasound Medical DevicesUltrasoundSafety Communication
05/10/2023Update: Use of Renuvion/J-Plasma Device for Certain Aesthetic ProceduresPlastic and Reconstructive SurgerySafety Communication
05/04/2023Do Not Use Certain SD Biosensor Pilot COVID-19 At-Home TestsIn Vitro DiagnosticsSafety Communication
04/12/2023Update: Recommendations for Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face MasksSurgical N95 respirators,
surgical masks,
pediatric face masks 		Safety Communication
03/30/2023Evaluation of Safety Concerns with Certain Dental Devices Used on AdultsDental DevicesSafety Communication
03/23/2023Risks with Exactech Joint Replacement Devices with Defective PackagingJoint ReplacementSafety Communication
03/08/2023Updated: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants MammographySafety Communication
02/07/2023Updated: Mammography Problems at Advanced Women Imaging in Guttenberg, NJMammographySafety Communication