Browse Device Recalls
3,007 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,007 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 3,007 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 4, 2021 | Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated... | Due to the configuration of certain Windows Service Permissions within the operating systems of... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 3, 2021 | Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed t... | SOMATOM systems-issues in with software syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a, may result in... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 2, 2021 | Synapse PACS - Radiological Image Processing System - Product Usage: intended... | The wrong patient information may be displayed in the viewer or PowerJacket. | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| Mar 1, 2021 | ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System). | In case of a failed automatic marker detection, a software error causes parts of the display to ... | Class II | Brainlab AG |
| Mar 1, 2021 | Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by... | Arietta 850 software version 4.0.0., 4.0.1, and 4.0.2 has an error in the focus point and transdu... | Class II | Hitachi Medical Systems America Inc |
| Mar 1, 2021 | Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0... | Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software U... | Class II | Abiomed, Inc. |
| Feb 26, 2021 | CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable,... | Erroneously high FeNO levels which may contribute to premature discontinuation of effective asthm... | Class II | CAIRE DIAGNOSTICS INC |
| Feb 25, 2021 | BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Mod... | Their is a potential that the automated staining instrument with software version 3.5.3.1 may mo... | Class II | Biocare Medical, LLC |
| Feb 22, 2021 | Mindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 ... | BeneVision DMS may intermittently freeze and require a manual reboot after which normal operation... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Feb 22, 2021 | RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7,... | For some LINAC types, merging clinical beams with beams of approximate dose may lead to the appro... | Class II | RAYSEARCH LABORATORIES AB |
| Feb 2, 2021 | IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Softw... | Manufacturing failed to follow process steps resulting in the distribution of potentially defecti... | Class II | Philips North America Llc |
| Feb 1, 2021 | Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910 | Due to software defect, under certain assay parameters, false Vitamin D results may be reported. ... | Class II | Thermo Fisher Scientific |
| Jan 28, 2021 | VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the ext... | bioM¿rieux has identified a potential safety risk worst case of a false susceptible erroneous tes... | Class II | Biomerieux Inc |
| Jan 28, 2021 | VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with... | bioM¿rieux has identified a potential safety risk worst case of a false susceptible erroneous tes... | Class II | Biomerieux Inc |
| Jan 27, 2021 | Sensis / Sensis Vibe systems with software version VD12 and equipped with HP ... | System may sporadically freeze (lock-up) during operation or while being in an idle state, no lon... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 22, 2021 | Radiation therapy software, RayStation standalone software treatment planning... | A software bug affecting results when using deep learning (DL) segmentation followed by geometric... | Class II | RaySearch America Inc |
| Jan 5, 2021 | Nucleic acid-based in vitro diagnostic devices for the detection of 2019-nove... | Users cannot complete testing due to a sign-error in the software component that controls the fil... | Class III | Biomeme, Inc. |
| Dec 24, 2020 | PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgra... | Patient tabletop moved out to the home position during scan initialization, may cause operator/by... | Class II | Philips North America |
| Dec 22, 2020 | The EOSedge system may acquire two simultaneous orthogonal planar images for ... | Inadequate images resizing and 2D measurement errors may occur when biplanar acquisition has been... | Class II | EOS Imaging |
| Dec 18, 2020 | ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 ... | Misleading error messages and a gap in the Operator Manual which affects ARTIS Icono biplane or A... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 17, 2020 | A calculator/data processing module for clinical use is an electronic device ... | A software error results in the unintentional removal of the serum-indices flag that would otherw... | Class II | Roche Diagnostics Operations, Inc. |
| Dec 14, 2020 | Neuroreader Medical Image Processing Software - Product Usage: intended to au... | The Neuroreader has been distributed with a reference normative database that is different from ... | Class II | Brainreader ApS |
| Dec 11, 2020 | FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: in... | The software does not update measurements and calculations in the Clinical Reporting Application ... | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| Dec 7, 2020 | IOLMaster 700 | When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient ... | Class II | Carl Zeiss Meditec AG |
| 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 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Pr... | There is a potential software error during programming. | Class II | Baxter Healthcare Corporation |
| Nov 23, 2020 | Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usa... | There is a potential software error during programming. | Class II | Baxter Healthcare Corporation |
| Nov 23, 2020 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Pr... | There is a potential software error during programming. | Class II | Baxter Healthcare Corporation |
| Nov 23, 2020 | uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871... | When a user creates a measurement tool annotation in the uPath Enterprise software version 1.1, t... | Class II | Roche Molecular Systems, Inc. |
| Nov 23, 2020 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Pr... | There is a potential software error during programming. | Class II | Baxter Healthcare Corporation |
| Nov 20, 2020 | Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref ... | Software error -Software REF 615 588 versions 2.0 to 3.3, movement of the focusing is triggered b... | Class II | Haag-Streit USA Inc |
| Nov 20, 2020 | VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product... | A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Nov 20, 2020 | enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN ... | A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Nov 19, 2020 | Emission Computed Tomography System Image Process System - Product Usage: int... | A software defect that has the potential to result in image misdiagnosis and incorrect treatment ... | Class II | Philips North America, LLC |
| Nov 19, 2020 | The cobas z 480 analyzer including dedicated software for IVD use is a plate-... | Dirty Lens May Cause Invalid or False Positive Results | Class II | Roche Molecular Systems, Inc. |
| Nov 19, 2020 | Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC ... | A software anomaly in the A620 Patient Programmer application was identified that results in fail... | Class II | Medtronic Neuromodulation |
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.