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 |
|---|---|---|---|---|
| Mar 3, 2020 | Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 -... | It is possible that the collimators have screw hole locations that were insufficiently tapped. T... | Class II | Capintec Inc |
| Nov 5, 2018 | Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077 | There is a potential for the spring arm failure as a result of a broken tension rod (a component ... | Class II | Capintec Inc |
| Nov 5, 2018 | Captus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138 | There is a potential for the spring arm failure as a result of a broken tension rod (a component ... | Class II | Capintec Inc |
| Jul 24, 2012 | Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended ... | Customers who received a Capintec Captus 3000 Thyroid Uptake System with Software Revisions 1.22,... | Class II | Capintec 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.