Browse Device Recalls
20 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 20 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 20 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 7, 2025 | epoc BGEM BUN Test Card [25pk]. Material Number: 10736515. | Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some e... | Class II | Siemens Healthcare Diagnostics Inc |
| Mar 31, 2025 | Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparin... | Siemens Healthcare Diagnostics Inc., is recalling their Stratus CS Acute Care cTNI TestPak, an IV... | Class II | Siemens Healthcare Diagnostics Inc |
| Sep 24, 2024 | epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515 | Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in one lo... | Class II | Siemens Healthcare Diagnostics Inc |
| Oct 19, 2023 | epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), ... | Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certai... | Class II | Siemens Healthcare Diagnostics Inc |
| Feb 9, 2022 | Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644 | Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting q... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 9, 2022 | Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 1... | Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting q... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 9, 2022 | Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637 | Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting q... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 9, 2022 | Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637 | Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting q... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 3, 2021 | Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: use... | Siemens Healthcare Diagnostics Inc. has confirmed the potential for erroneous results due to disc... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 15, 2020 | Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SM... | Flexible tubing connected to the liquid waste bottle can crack during routine customer maintenanc... | Class II | Siemens Healthcare Diagnostics Inc. |
| May 15, 2020 | Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #1... | Flexible tubing connected to the liquid waste bottle can crack during routine customer maintenanc... | Class II | Siemens Healthcare Diagnostics Inc. |
| May 11, 2016 | Hettich Centrifuge Modules: StreamLAB Centrifuge Module (10372372 or 1044480... | Premature bucket failures | Class II | Siemens Healthcare Diagnostics Inc. |
| Mar 24, 2016 | Dimension Vista 1500 Intelligent Lab System running on software versions V.3.... | Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confir... | Class II | Siemens Healthcare Diagnostics Inc. |
| Mar 24, 2016 | Dimension Vista 500 Intelligent Lab System running on software versions V.3.6... | Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confir... | Class II | Siemens Healthcare Diagnostics Inc. |
| Nov 10, 2015 | Reagent Management System (RMS) Dimension RxL Max w/o HM Product Usage: T... | Siemens has identified RMS refrigeration compressors that are missing the safety cover on the el... | Class II | Siemens Healthcare Diagnostics Inc. |
| Nov 10, 2015 | Reagent Management System (RMS) Dimension EXL with LM Product Usage: Th... | Siemens has identified RMS refrigeration compressors that are missing the safety cover on the el... | Class II | Siemens Healthcare Diagnostics Inc. |
| Nov 10, 2015 | Reagent Management System (RMS) Dimension RxL Max HM STM Product Usage: ... | Siemens has identified RMS refrigeration compressors that are missing the safety cover on the el... | Class II | Siemens Healthcare Diagnostics Inc. |
| Nov 10, 2015 | Reagent Management System (RMS) Dimension EXL with LM STM Product Usage:... | Siemens has identified RMS refrigeration compressors that are missing the safety cover on the el... | Class II | Siemens Healthcare Diagnostics Inc. |
| Jun 9, 2014 | Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Sie... | The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to altern... | Class II | Siemens Healthcare Diagnostics Inc. |
| Mar 6, 2013 | Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-20... | Customer complaint investigation confirmed the issue of false skipped wells and false susceptible... | 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.