Browse Device Recalls
456 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 456 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 456 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 7, 2012 | Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classi... | The recalling firm has discovered that when using a Sysmex(R) CA-7000 or CA-1500 coagulation anal... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 7, 2012 | Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502... | Siemens has confirmed that the Stratus(R) CS Acute Care(TM) D-Dimer CalPak calibrator lots 502058... | Class III | Siemens Healthcare Diagnostics, Inc. |
| May 29, 2012 | syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. ... | When using the syngo Quality Control package the system may not perform as intended for Multi-Rul... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 29, 2012 | EasyLink Informatic System is included with the Dimension Vista System. The ... | When using the EasyLink Quality Control Package the system may not perform as intended for Multi-... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 8, 2012 | Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B1... | Siemens Healthcare Diagnostics has confirmed that the presence of Intrinsic Factor Blocking Antib... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 1, 2010 | BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usag... | Firm has confirmed that if the Cleaner SCS vial becomes empty after processing a test for Antithr... | Class II | Siemens Healthcare Diagnostics, 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.