Medical Device Safety Alerts
Consumer-oriented medical device informationMedical 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.
Class I Recall for Stay-Safe Catheter Extension Sets and Adapters
Urgent Class I Recall Notice FDA has issued a Class I recall – the most serious type – for certain medical devices manufactured by Fresenius Medical Care. The recall concerns Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapters, pivotal components used...
Abbott/Thoratec Recalls HeartMate II and HeartMate 3 LVAS
Recall Alert: HeartMate II and HeartMate 3 Left Ventricular Assist Systems (LVAS) The FDA has issued a Class I recall, the most serious type, for the HeartMate II and HeartMate 3 Left Ventricular Assist Systems (LVAS) due to potential serious injuries or death...
Medical Device FDA Safety Alerts
| Date | Subject | Product area | More information |
|---|---|---|---|
| 03/19/2024 | Update: Evaluating Plastic Syringes Made in China for Potential Device Failures | Syringes | Safety Communication |
| 02/29/2024 | Hintermann Series H3 Total Ankle Replacement Has a Higher-Than-Expected Risk of Device Failure | Joint Replacement | Safety Communication |
| 02/27/2024 | BioZorb Markers and Potential Risks with Use in Breast Tissue | Breast Tissue | Safety Communication |
| 02/21/2024 | Do Not Use Smartwatches or Smart Rings to Measure Blood Glucose Levels | Blood Glucose | Safety Communication |
| 02/02/2024 | Do Not Use Certain Cardinal Health Monoject Luer-Lock and Enteral Syringes | Syringes | Safety Communication |
| 01/18/2024 | Certain ResMed Ltd Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices | BiPAP, CPAP Machines | Safety Communication |
| 01/16/2024 | Risks with Exactech Equinoxe Shoulder System with Defective Packaging | Joint Replacement | Safety Communication |
| 01/03/2024 | Do Not Use Synovo Total Hip Resurfacing System | Implants | Safety Communication |
| 11/30/2023 | Evaluating Plastic Syringes Made in China for Potential Device Failures | Syringes | Safety Communication |
| 11/28/2023 | Carefully Monitor Philips DreamStation 2 CPAP Machines for Signs of Overheating | CPAP Machine | Safety Communication |
| 11/21/2023 | Voluntary Recall of SoClean Equipment Intended for Use with CPAP Devices and Accessories | Cleaner | Safety Communication |
| 11/06/2023 | Recall of Certain Saline and Sterile Water Medical Products Associated with Nurse Assist | Saline, Sterile Water Medical Products | Safety Communication |
| 09/29/2023 | Update: Recommendations for Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks | Surgical N95 respirators, surgical masks, pediatric face masks | Safety Communication |
| 08/11/2023 | Do Not Use Tests Manufactured by Universal Meditech, Inc. | In Vitro Diagnostics | Safety Communication |
| 07/17/2023 | Do Not Use RoyalVibe Health, CellQuicken, or Well-Being Reality Ultrasound Medical Devices | Ultrasound | Safety Communication |
| 05/10/2023 | Update: Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures | Plastic and Reconstructive Surgery | Safety Communication |
| 05/04/2023 | Do Not Use Certain SD Biosensor Pilot COVID-19 At-Home Tests | In Vitro Diagnostics | Safety Communication |
| 04/12/2023 | Update: Recommendations for Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks | Surgical N95 respirators, surgical masks, pediatric face masks | Safety Communication |
| 03/30/2023 | Evaluation of Safety Concerns with Certain Dental Devices Used on Adults | Dental Devices | Safety Communication |
| 03/23/2023 | Risks with Exactech Joint Replacement Devices with Defective Packaging | Joint Replacement | Safety Communication |
| 03/08/2023 | Updated: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants | Mammography | Safety Communication |
| 02/07/2023 | Updated: Mammography Problems at Advanced Women Imaging in Guttenberg, NJ | Mammography | Safety Communication |