Browse Device Recalls
4 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4 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 4 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 5, 2017 | MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation. | The firm received complaints that involved an unanticipated interaction between a NeuroBlate syst... | Class I | Monteris Medical Corp |
| Mar 25, 2016 | NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO... | Monteris received a report that the sapphire lens on a 2.2SF probe fractured during a LITT proced... | Class I | Monteris Medical Corp |
| Oct 3, 2014 | SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP4... | Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser d... | Class II | Monteris Medical Corp |
| Oct 3, 2014 | FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DT... | Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser d... | Class II | Monteris Medical Corp |
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.