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 |
|---|---|---|---|---|
| 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. |
| 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 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. |
| May 3, 2019 | Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number... | A steady upward trend in blank (u) absorbance was observed | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 3, 2019 | ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Nu... | A steady upward trend in blank (u) absorbance was observed | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 7, 2019 | Atellica IM 1300 Analyzer, Material Number 11066001 | There were multiple issues identified in the system software which required an update. | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 7, 2019 | Atellica Sample Handler Prime, Material Number 11069001 | There were multiple issues identified in the system software which required an update. | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 7, 2019 | Atellica IM 1600 Analyzer, Material Number 11066000 | There were multiple issues identified in the system software which required an update. | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 12, 2018 | Dimension Vista 500, Analyzer, chemistry Model no. 10284473 | When the Millipore Water Purification Module Progard Pretreatment Packs are used with Dimension V... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 12, 2018 | Dimension Vista 1500, Analyzer, chemistry Model no. 10444801 | When the Millipore Water Purification Module Progard Pretreatment Packs are used with Dimension V... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 16, 2018 | Dimension Vista 1500, Model No. 10444801 an in vitro diagnostic device intend... | Siemens Healthcare Diagnostics has identified an issue with Dimension Vista software v.3.7 and v.... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 16, 2018 | Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intende... | Siemens Healthcare Diagnostics has identified an issue with Dimension Vista software v.3.7 and v.... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 11, 2018 | Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vit... | Siemens Healthcare Diagnostics has confirmed that Dimension Vista Lactate Dehydrogenase (LDI) ma... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 28, 2018 | Dimension Thermal Chamber Motor Cable located in the following models: Model... | Thermal chamber motors have electrical cables with single insulation rather than the required dou... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 26, 2018 | Atellica Sample Handler Prime. In vitro diagnostic testing of clinical specim... | Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellic... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 26, 2018 | Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens ... | Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellic... | 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.