Browse Device Recalls
454 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 454 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 454 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 29, 2016 | CentraLink¿ Data Management System Software Versions: v13x,v14x,v15x The C... | There is a remote possibility CentraLink may download an order to the ADVIA Automation System wit... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 22, 2016 | SIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH (Parathyroid Hormone) T... | Siemens is conducting this recall for the IMMULITE¿ 2000/IMMULITE¿ 2000 XPi Intact PTH (Intact Pa... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 18, 2016 | IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay... | Siemens Healthcare Diagnostics confirmed that the IMMULITE 2000/ IMMULITE 2000 XPi Systems PSA a... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 18, 2016 | IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Cat... | Siemens Healthcare Diagnostics has confirmed that the IMMULITE/ IMMULITE 1000 Systems PSA assays ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 21, 2016 | ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD. | Siemens is investigating an issue which may cause an incorrect result to be reported. Siemens rec... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 7, 2016 | Advia Chemistry Calibrator For in vitro diagnostic use in the calibration o... | Siemens has confirmed that the DBIL_2 Assigned Calibrator Values (ACV) currently assigned to the ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 29, 2016 | FlexLab Automation Modules | Class II | Siemens Healthcare Diagnostics, Inc. | |
| Sep 29, 2016 | Aptio Automation Modules | Possible overheating of power cord plugs used to connect to FlexLab and Aptio Automation systems. | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 15, 2016 | Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) i... | Siemens determined that discrepant low calcium recovery of QC and patient samples can occur with ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 30, 2016 | IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay, REF/Catalog Number ... | Multiple customers reported seeing an increase in imprecision with some patients resulting in hig... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 30, 2016 | IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D... | Multiple customers reported seeing an increase in imprecision with some patients resulting in hig... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 25, 2016 | Dimension IRON Flex reagent cartridges | Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and D... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Aug 25, 2016 | Dimension Vista IRON Flex reagent cartridges | Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and D... | Class III | Siemens Healthcare Diagnostics, Inc. |
| 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 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. |
| 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 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. |
| 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 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. |
| Jan 14, 2016 | BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in v... | False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also a... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 14, 2016 | BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for i... | False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also a... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 19, 2015 | Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Num... | Factor VIII Chromogenic Assay Lot 44637 is showing an increased occurrence of irregular curves wh... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 3, 2015 | Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine sta... | Siemens Healthcare Diagnostics has confirmed an increase in the rate of Abnormal Assay errors a... | 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.