Browse Device Recalls
3,099 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,099 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 3,099 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 14, 2022 | cobas e801 Immunoassay Analyzer | Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The... | Class II | Roche Diagnostics Operations, Inc. |
| Jul 14, 2022 | Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Artic... | Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recov... | Class II | Aesculap Implant Systems LLC |
| Jul 13, 2022 | VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only),... | There are 7 reported software anomalies that may affect use of the device. | Class II | bioMerieux, Inc. |
| Jul 12, 2022 | Surpria: Software Version V3.11, V3.22 | Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstruc... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jul 12, 2022 | SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C | Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstruc... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jul 12, 2022 | Surpria 64: Software Version V3.11, V3.22 | Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstruc... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jul 8, 2022 | Pentacam HR REF 70900. Used to image the anterior segment of the eye. | Due to a software issue, IOL calculator printout often does not accurately reflect the alignment ... | Class II | Oculus Optikgeraete GMBH |
| Jul 8, 2022 | Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye. | Due to a software issue, IOL calculator printout often does not accurately reflect the alignment ... | Class II | Oculus Optikgeraete GMBH |
| Jul 8, 2022 | Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior... | Due to a software issue, IOL calculator printout often does not accurately reflect the alignment ... | Class II | Oculus Optikgeraete GMBH |
| Jul 7, 2022 | The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the Z... | There is potential for unanticipated software anomalies to occur when using the Model 2868 Applic... | Class II | Boston Scientific Corporation |
| Jul 7, 2022 | The PRM is intended to be used as part of the ZOOM LATITUDE Programming Syste... | There is potential for unanticipated software anomalies to occur when using the Model 2868 Applic... | Class II | Boston Scientific Corporation |
| Jul 7, 2022 | The PRM is intended to be used as part of the ZOOM LATITUDE Programming Syste... | There is potential for unanticipated software anomalies to occur when using the Model 2868 Applic... | Class II | Boston Scientific Corporation |
| Jul 5, 2022 | ZAP-X Radiosurgery System | Software issue identified in cases of initial patient setup with large (greater-than-or-equal-to ... | Class II | Zap Surgical Systems |
| Jun 23, 2022 | INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) ... | The INOmax DSIR Delivery System, manufactured by Mallinckrodt Pharmaceuticals, is not compatible ... | Class II | Mallinckrodt, LLC. |
| Jun 23, 2022 | Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and an... | A race condition between the storage system and services database has the potential to revert edi... | Class II | DICOM Grid, Inc. d/b/a Ambra Health |
| Jun 22, 2022 | ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: ... | There is a potential risk of medication error when using specific Abacus Order Entry & Calculatio... | Class I | Baxter Healthcare Corporation |
| Jun 17, 2022 | Merlin.net model MN5000 Software | The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrog... | Class II | St. Jude Medical, Cardiac Rhythm Management Div... |
| Jun 17, 2022 | Merlin PCS 3650 programmer Model 3330 software | There is a potential for programmer software (Merlin PCS) and remote monitoring software applicat... | Class II | St. Jude Medical, Cardiac Rhythm Management Div... |
| Jun 17, 2022 | Merlin 2 PCS MER37000 programmer Model MER3400 software | The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrog... | Class II | St. Jude Medical, Cardiac Rhythm Management Div... |
| Jun 16, 2022 | nordicBrainEX, software versions 2.21 through 2.3.10 | When exporting merged results from the BOLD, DSC, and DCE modules of nordicBrainEx, where both th... | Class II | NordicNeuroLab AS |
| Jun 15, 2022 | Sensis Vibe Combo with software version VD12A. A diagnostic and administrati... | Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication du... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 15, 2022 | Sensis with software version VD12A. A diagnostic and administrative tool su... | Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication du... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 15, 2022 | SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-... | When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge t... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Jun 14, 2022 | Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1 | The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and ... | Class II | SIGHT DIAGNOSTICS LTD |
| Jun 14, 2022 | Centricity PACS Software Version 7.0 SP0.0.4.7 | The Event Notification Manager (ENM) functionality for certain products does not process notifica... | Class II | GE Healthcare, LLC |
| Jun 2, 2022 | Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilat... | A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into... | Class II | Breas Medical, Inc. |
| May 31, 2022 | NaviCare Nurse Call/Voalte Nurse Call | An issue has been identified with Phillips (Emergin) and Longleaf non relay (Connexall, Vocera, C... | Class II | Baxter Healthcare Corporation |
| May 31, 2022 | Xhibit Telemetry Receiver, Model: 96280 | Software related alarm escalation defect occurs after approximately 25 days of continuous use. Te... | Class II | Spacelabs Healthcare, Inc. |
| May 24, 2022 | t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insu... | Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate ... | Class II | Tandem Diabetes Care Inc |
| May 24, 2022 | BD Pyxis MedBank Cabinet Software v2.1.2.9 Legacy MedBank Cabinets with ... | The automated dispensing cabinet software update included a .dll file that is not compatible with... | Class II | CareFusion 303, Inc. |
| May 24, 2022 | t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insu... | Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate ... | Class II | Tandem Diabetes Care Inc |
| May 3, 2022 | NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2 | Software anomaly was identified. | Class II | Medtronic Xomed, Inc. |
| May 3, 2022 | NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2 | Software anomaly was identified. | Class II | Medtronic Xomed, Inc. |
| Apr 26, 2022 | 4 Series CX phototherapy units equipped with Daavlin's ClearLink Control Syst... | Software issue, resuming an interrupted treatment will result in swap of utilized calibration tre... | Class II | Daavlin Distributing Company |
| Apr 26, 2022 | 1 Series CX phototherapy units equipped with Daavlin's ClearLink Control Syst... | Software issue, resuming an interrupted treatment will result in swap of utilized calibration tre... | Class II | Daavlin Distributing Company |
| Apr 25, 2022 | CardioTek EP-TRACER Software V2.x. | Device did not pass electrical safety testing for adequate insulation. | Class II | CardioTek BV |
| Apr 22, 2022 | Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0... | Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed t... | Class II | Fresenius Kabi USA, LLC |
| Apr 21, 2022 | ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1... | Due to interference with the Live Listen feature of hearing aid or AirPods, the user's iPhone may... | Class II | Dain Technology, Inc. (Subsidiary of Soundable ... |
| Apr 19, 2022 | Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software ... | When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or... | Class II | Haemonetics Corporation |
| Apr 18, 2022 | Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-2... | Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audi... | Class I | Smiths Medical ASD Inc. |
| Apr 13, 2022 | Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 ... | Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis L... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 12, 2022 | Cobalt Models loaded with CareLink SmartSync Device Manager application softw... | Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrill... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 12, 2022 | Crome Models loaded with CareLink SmartSync Device Manager application softwa... | Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrill... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 7, 2022 | Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reor... | The problem is with the Bio-Rad VARIANT nbs Sickle Cell Program Resin Update CD-ROM software; Mod... | Class II | Bio-Rad Laboratories, Inc. |
| Mar 29, 2022 | The device is a whole-body CT x-ray system. The acquired x-ray transmission d... | Three software issues affecting incorrect image display, error interpreting patient images due to... | Class II | Philips North America Llc |
| Mar 29, 2022 | VITEK 2 Systems and VITEK 2 with MYLA. | Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and syner... | Class II | bioMerieux, Inc. |
| Mar 21, 2022 | ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0... | Software issue for treatment plan and image management application may result in mismatch values ... | Class II | Varian Medical Systems Imaging Laboratory GmbH |
| Mar 15, 2022 | PrisMax System, Product Code 955626 | This correction is due to software anomalies occurring during use. If the operator initiates ther... | Class II | Baxter Healthcare Corporation |
| Mar 15, 2022 | PrisMax System, Product Code 955724 | This correction is due to software anomalies occurring during use. If the operator initiates ther... | Class II | Baxter Healthcare Corporation |
| Mar 15, 2022 | PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701 | This correction is due to software anomalies occurring during use. If the operator initiates ther... | Class II | Baxter Healthcare Corporation |
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.