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 |
|---|---|---|---|---|
| Oct 15, 2021 | Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual ... | Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 15, 2021 | Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual ... | Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 6, 2021 | Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens C... | The Aptio Automation Firmware for the ADVIA Centaur XP/XPT Interface Module may lead, in some cas... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 20, 2021 | Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543 | The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 20, 2021 | Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151 | The firm has confirmed the potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reag... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 18, 2021 | The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723... | ADVIA Chemistry System and Software Versions (V1.4 SMN 11314625 and V1.4 China SMN 11316885) may ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 13, 2021 | Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic te... | Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 13, 2021 | Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic te... | Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 13, 2021 | Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic t... | Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 4, 2021 | Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Materia... | Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 5, 2021 | ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - US, automated hematolog... | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 5, 2021 | ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, automated hematology... | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 5, 2021 | ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - US, automated hematology a... | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 5, 2021 | ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - US, automated hematol... | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 5, 2021 | ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - OUS, automated ... | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 5, 2021 | ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, automated hematology ... | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 5, 2021 | ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - OUS, automated hematolo... | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 5, 2021 | ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - OUS, aut... | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 5, 2021 | ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, automated hematol... | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 5, 2021 | ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology ... | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 5, 2021 | ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology a... | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 5, 2021 | ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, automated hematology a... | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 5, 2021 | ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated... | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 5, 2021 | ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology ... | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 5, 2021 | ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated he... | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 5, 2021 | ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, automated hematology... | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 5, 2021 | ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated h... | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 5, 2021 | ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated h... | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 5, 2021 | ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US, aut... | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 5, 2021 | ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated ... | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 2, 2021 | BCS XP System: Multipurpose system for in vitro coagulation studies. Product ... | Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 8, 2021 | Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2 | Potential false positive HSV results. Siemens Healthcare Diagnostics, Inc. initiated a correctio... | 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. |
| Dec 2, 2020 | Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens... | Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient res... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 2, 2020 | Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens.... | Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient res... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 2, 2020 | Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens... | Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient res... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 23, 2020 | ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro ... | Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Reagent may demonst... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 23, 2020 | Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vit... | Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Reagent may demonst... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 26, 2020 | Atellica IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers d... | Test Definition scanning may reset custom settings to defaults. When a 2D Master Curve and TDef b... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 26, 2020 | Atellica IM 1300 Analyzer - Product Usage: automated, immunoassay analyzers d... | Test Definition scanning may reset custom settings to defaults causing falsely low or high result... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 22, 2020 | Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the qu... | Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring ra... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 22, 2020 | ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in th... | Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring ra... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 25, 2020 | Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - ... | Low outlier resultsgenerated with Alkaline Phosphatase (ALPI) Flex reagent cartridge.The maximum ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 19, 2020 | Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-... | Positive bias across the Analytical Measurement Range of the TNIH assay compared to an unaffected... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 24, 2020 | Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD... | Dimension Vista High Sensitivity Troponin I (TNIH) may exhibit a negative bias with patient samples | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 30, 2020 | DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015... | If DCA Vantage Analyzer is configured to run Code 39 with check digit, the scanner is not confirm... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 5, 2020 | Atellica CH Chemistry Calibrator | Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemi... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 5, 2020 | ADVIA Chemistry Calibrator | Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemi... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 15, 2020 | (1) Atellica Data Manager software version 1.0 Siemens Material Number (SMN)... | Unexpected interface driver behavior identified (QC) Results May Be Assigned to an Incorrect Cont... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 15, 2020 | (1) CentraLink Data Management System software version 16.0.2 Siemens Materia... | Unexpected interface driver behavior identified (QC) Results May Be Assigned to an Incorrect Cont... | 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.