Browse Device Recalls
106 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 106 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 106 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 18, 2012 | MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) u... | A patient was seriously mistreated after a user made and saved an inadvertent change to the defin... | Class II | Elekta, Inc. |
| Aug 21, 2012 | Oncentra External Beam 4.1. Radiation treatment planning software designed... | During the planning process the beam weights can be changed by the customers. When the beam weigh... | Class II | Elekta, Inc. |
| Aug 6, 2012 | Precise Digital Accelerator Delivery of radiation to defined target volumes | There have been a small number of instances in hospitals where the joint between the drive gear a... | Class II | Elekta, Inc. |
| Jul 27, 2012 | Multileaf Collimator To be used for single or multiple fractions, delivere... | Information released with the product Agility did not originally contain information on compatibi... | Class II | Elekta, Inc. |
| Jun 21, 2012 | Monaco Product Usage: Planning of radiation therapy | Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM ... | Class II | Elekta, Inc. |
| Jun 21, 2012 | Focal SIM Planning of radiation therapy | Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM ... | Class II | Elekta, Inc. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.