Browse Device Recalls

688 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 688 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 688 FDA device recalls.

Clear
DateProductReasonClassFirm
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 28, 2020 Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative t... Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Potentia... Class II Siemens Healthcare Diagnostics Inc
Aug 25, 2020 Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI... Siemens confirmed that the Upper Limit of Normal (ULN) as claimed in the Instructions for Use (IF... 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 27, 2020 RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens M... The scanner is not confirming the integrity of read barcode data using the check-digit when readi... 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 (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 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 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.
May 7, 2020 Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00... Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample ... Class II Siemens Healthcare Diagnostics, Inc.
May 7, 2020 Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00... Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample ... Class II Siemens Healthcare Diagnostics, Inc.
May 4, 2020 ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI... The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause i... Class II Siemens Healthcare Diagnostics, Inc.
May 4, 2020 Dimension Vista Enzymatic Creatinine, Siemens Material Number 10700444, UDI N... The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause i... Class II Siemens Healthcare Diagnostics, Inc.
May 4, 2020 Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number ... The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause i... Class II Siemens Healthcare Diagnostics, Inc.
May 4, 2020 Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UD... The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause i... Class II Siemens Healthcare Diagnostics, Inc.
May 4, 2020 Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Num... The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause i... Class II Siemens Healthcare Diagnostics, Inc.
May 4, 2020 ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941... The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause i... Class II Siemens Healthcare Diagnostics, Inc.
Feb 27, 2020 Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software vers... Editing an assay Test Definition and switching to another assay s Test Definition screen without ... Class II Siemens Healthcare Diagnostics, Inc.
Feb 14, 2020 Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 1109... The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibratio... Class II Siemens Healthcare Diagnostics, Inc.
Feb 13, 2020 Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determinatio... Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy Class II Siemens Healthcare Diagnostics, Inc.
Feb 13, 2020 Dimension Vista¿ Total Bilirubin Flex¿ reagent cartridge -In vitro Diagnost... Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy Class II Siemens Healthcare Diagnostics, Inc.
Feb 13, 2020 ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (7... Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy Class II Siemens Healthcare Diagnostics, Inc.
Feb 13, 2020 Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination... Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy Class II Siemens Healthcare Diagnostics, Inc.
Feb 13, 2020 Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for th... Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy 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.