Browse Device Recalls
3 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3 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 3 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 6, 2019 | DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone... | Salivary Progesterone assay may observe a higher percentage of samples with low results. Saliva s... | Class II | DRG Instruments GmbH |
| May 21, 2019 | DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human ... | Salivary assay may observe a higher percentage of samples with 0 pg/ml testosterone or results wh... | Class II | DRG Instruments GmbH |
| Jul 14, 2016 | Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measu... | Lower recovery of salivary estradiol levels due to poor differentiation between kit Standard 0 an... | Class II | DRG Instruments GmbH |
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.