Browse Device Recalls
700 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 700 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 700 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 24, 2016 | SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number ... | Siemens received multiple customer complaints indicating an increase in false positive and indete... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 24, 2016 | SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number ... | Siemens received multiple customer complaints indicating an increase in false positive and indete... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 11, 2016 | Siemens RAPIDPoint¿ 400 Blood Gas Analyzer Siemens Material Number (SMN): 1... | There is a potential for the first and/or last name of one patient to be printed with Patient ID ... | Class II | Siemens Healthcare Diagnostics Inc |
| Aug 11, 2016 | RAPIDLab 1245 Blood Gas Analyzer Siemens Material Number (SMN): 10321844, 1... | There is a potential for the first and/or last name of one patient to be printed with Patient ID ... | Class II | Siemens Healthcare Diagnostics Inc |
| Aug 11, 2016 | Siemens RAPIDLab 1240 Blood Gas Analyzer Siemens Material Number (SMN): 103... | There is a potential for the first and/or last name of one patient to be printed with Patient ID ... | Class II | Siemens Healthcare Diagnostics Inc |
| Aug 11, 2016 | Siemens RAPIDPoint 500 Blood Gas Analyzer Siemens Material Number (SMN): ... | There is a potential for the first and/or last name of one patient to be printed with Patient ID ... | Class II | Siemens Healthcare Diagnostics Inc |
| Aug 11, 2016 | RAPIDLab 1260 Blood Gas Analyzer Siemens Material Number (SMN): 10321846, 1... | There is a potential for the first and/or last name of one patient to be printed with Patient ID ... | Class II | Siemens Healthcare Diagnostics Inc |
| Aug 11, 2016 | RAPIDLab 1265 Blood Gas Analyzer Siemens Material Number (SMN): 10321852, 1... | There is a potential for the first and/or last name of one patient to be printed with Patient ID ... | Class II | Siemens Healthcare Diagnostics Inc |
| Aug 11, 2016 | Siemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number (SMN... | There is a potential for the first and/or last name of one patient to be printed with Patient ID ... | Class II | Siemens Healthcare Diagnostics Inc |
| Aug 9, 2016 | ADVIA Centaur¿ PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/S... | Communication provided to emphasize that the PSA values should be interpreted in accordance with ... | Class II | Siemens Healthcare Diagnostics, Inc |
| Aug 8, 2016 | Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrat... | Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from... | Class II | Siemens Healthcare Diagnostics, Inc |
| Aug 3, 2016 | Dimension Vista¿ Calcium (CA) Flex¿ reagent cartridge Device Listing No.: D... | Siemens Healthcare Diagnostics determined that the Dimension Vista Calcium (CA) Flex reagent cart... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 20, 2016 | ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA... | Siemens identified an issue with the ratio equation provided on the ADVIA Chemistry XPT System So... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 5, 2016 | Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software ... | Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the ... | Class III | Siemens Healthcare Diagnostics Inc |
| Jun 22, 2016 | Stratus¿ CS STAT Fluorometric Analyzer-microprocessor-controlled instrument ... | Software defect, where either an Above Assay Range or an inaccurate value could potentially be re... | Class II | Siemens Healthcare Diagnostics Inc |
| Jun 17, 2016 | Syva¿ EMIT¿ 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogene... | Siemens Healthcare Diagnostics has confirmed the Syva¿ EMIT¿ 2000 Theophylline reagent lot G3, wh... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 17, 2016 | ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vit... | Siemens Healthcare Diagnostics has confirmed the Syva¿ EMIT¿ 2000 Theophylline reagent lot G3, wh... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 26, 2016 | ADVIA¿ Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 108197... | Eight (8) issues were identified which may affect the results generated by the system software ve... | 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. |
| May 5, 2016 | The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration... | Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the... | Class III | Siemens Healthcare Diagnostics, Inc. |
| May 5, 2016 | The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Am... | Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the... | Class III | Siemens Healthcare Diagnostics, Inc. |
| May 2, 2016 | Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for qu... | Exhibits a greater than 10% change in results in samples with biotin levels up to 10 ng/mL (41 nm... | Class II | Siemens Healthcare Diagnostics, Inc |
| Apr 28, 2016 | ADVIA Centaur XPT Immunoassay System | The ADVIA Centaur¿ XPT default setting for the Daily Maintenance Task (Daily Cleaning Procedure) ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 15, 2016 | IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insu... | 24 minutes of incubation is required prior to processing patient samples and for the pretreatment... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 30, 2016 | ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710,... | The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two ina... | Class III | 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. |
| Mar 17, 2016 | ADVIA CHEMISTRY ENZYMATIC CREATININE_2 | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 17, 2016 | Advia Chemistry Assay: LDL Cholesterol, Direct | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 17, 2016 | Dimension Assays: Uric Acid (URCA) | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 17, 2016 | Advia Chemistry Assay: Lactate | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 17, 2016 | Dimension Vista Assays: Enzymatic Creatine (ECRE) | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 17, 2016 | Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Chol... | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 17, 2016 | Advia Chemistry Assay: Uric Acid and Uric Acid, concentrated | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 17, 2016 | Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL) | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 17, 2016 | Dimension Vista Assays: Uric Acid (URCA) | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 17, 2016 | Dimension Vista Assays: Direct HDL Cholesterol (AHDL) | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 17, 2016 | ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY TRIGLYCERI... | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 17, 2016 | Dimension Vista Assays: Triglycerides (TRIG) | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 17, 2016 | Dimension Assays: Direct HDL Cholesterol (AHDL) | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 17, 2016 | Dimension Assays: ENZYMATIC CREATININE | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 17, 2016 | ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose & Concentra... | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 17, 2016 | Dimension Assays: Triglycerides (TGL) | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyron... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 10, 2016 | ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD ... | Software anomaly; Siemens identified that software version 1.4.2133 on the ADVIA 560 Hematology S... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 8, 2016 | Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended fo... | Siemens Healthcare Diagnostics confirmed that Syva Emit Methotrexate Application (DVMTX.1) for Di... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 7, 2016 | ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 1069757... | Siemens Healthcare Diagnostics has confirmed the ADVIA Chemistry Triglyceride concentrated reagen... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 16, 2016 | Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN m... | Siemens Healthcare Diagnostics has determined that Dimension Vista Blood Urea Nitrogen (BUN) lots... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 9, 2016 | Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge ... | Siemens Healthcare Diagnostics has received customer complaints regarding QC shifts and imprecisi... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 4, 2016 | Siemens Healthcare Diagnostic ADVIA Centaur Calibrator E- 6- Pack (Reference)... | ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay | Class II | Siemens Healthcare Diagnostics, Inc |
| Feb 4, 2016 | Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E - 2-Pack Catalog... | ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay | 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.