Browse Device Recalls

571 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 571 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 571 FDA device recalls.

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DateProductReasonClassFirm
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 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.
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.
Feb 13, 2020 ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & 10341113 (... Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy Class II Siemens Healthcare Diagnostics, Inc.
Feb 5, 2020 IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and OUS: LKE21 - ... Due to high discordant Estradiol results which.potentially affects all patient populations, A fal... Class II Siemens Healthcare Diagnostics, Inc.
Feb 5, 2020 IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L... Due to high discordant Estradiol results which.potentially affects all patient populations, A fal... Class II Siemens Healthcare Diagnostics, Inc.
Jan 12, 2020 Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143 Some lots ending in "17", "18", "19", or higher may have cuvette defects allowing water from the ... Class II Siemens Healthcare Diagnostics, Inc.
Jan 6, 2020 Atellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software... A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired. Class II Siemens Healthcare Diagnostics, Inc.
Jan 6, 2020 Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software... A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired. Class II Siemens Healthcare Diagnostics, Inc.
Dec 20, 2019 ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. ... Firm has received customer complaints regarding failed calibrations and increased imprecision of ... Class II Siemens Healthcare Diagnostics, Inc.
Dec 18, 2019 ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869 There is a potential for falsely depressed creatinine results for patients on phenindione therapy... Class II Siemens Healthcare Diagnostics, Inc.
Dec 18, 2019 Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520 There is a potential for falsely depressed creatinine results for patients on phenindione therapy... Class II Siemens Healthcare Diagnostics, Inc.
Dec 18, 2019 Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533 There is a potential for falsely depressed creatinine results for patients on phenindione therapy... Class II Siemens Healthcare Diagnostics, Inc.
Dec 18, 2019 Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444 There is a potential for falsely depressed creatinine results for patients on phenindione therapy... Class II Siemens Healthcare Diagnostics, Inc.
Nov 19, 2019 Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator - Product ... Atellica CH: The Atellica¿ CH High Sensitivity CReactive Protein Calibrator (hsCRP CAL) is for in... Class II Siemens Healthcare Diagnostics, Inc.
Nov 19, 2019 ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calib... Atellica and ADVIA hsCRP calibrator accuracy has drifted away from the reference materials (ERM-D... Class II Siemens Healthcare Diagnostics, Inc.
Oct 11, 2019 Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions... On the Atellica CH 930 Analyzer, when scanning barcodes at the module console for Integrated Mult... Class II Siemens Healthcare Diagnostics, Inc.
Sep 23, 2019 Atellica CH 930 Analyzer Potential for calibration error resulting in QC failures after the calibration run with QC and pa... Class II Siemens Healthcare Diagnostics, Inc.
Aug 15, 2019 Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Materia... Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM... Class II Siemens Healthcare Diagnostics, Inc.
Aug 15, 2019 Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material... Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM... Class II Siemens Healthcare Diagnostics, Inc.
Aug 14, 2019 Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 (100... Atellica IM anti-CCP IgG (aCCP) Test Definition (TDef) Mitigation Failure-reagent carryover mitig... Class II Siemens Healthcare Diagnostics, Inc
Jul 30, 2019 Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 ... Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.... Class II Siemens Healthcare Diagnostics, Inc.
Jul 22, 2019 Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in s... Homocysteine Assay May Cause Elevated Results in the Folate Assay Class II Siemens Healthcare Diagnostics, Inc
Jul 22, 2019 Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red... Homocysteine Assay May Cause Elevated Results in the Folate Assay Class II Siemens Healthcare Diagnostics, Inc
Jul 22, 2019 Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red b... Homocysteine Assay May Cause Elevated Results in the Folate Assay Class II Siemens Healthcare Diagnostics, Inc
Jul 15, 2019 Dimension¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR Product Usage:... Negative Bias with Lot EA9227. Class II Siemens Healthcare Diagnostics, Inc.
Jul 10, 2019 IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2K... There is a potential for low discordant progesterone results on a subset of patient samples. A f... Class II Siemens Healthcare Diagnostics, Inc.
Jul 10, 2019 IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128 There is a potential for low discordant progesterone results on a subset of patient samples. A f... Class II Siemens Healthcare Diagnostics, Inc.
Jun 27, 2019 N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative de... Iincreased (falsely elevated) Albumin results compared to expected results 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.