Browse Device Recalls
3,235 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,235 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 3,235 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Mar 11, 2022 | VELYS Robotic-Assisted Solution Base Product No.: 451570100 | System software v1.5.1 has a system software issue related to the Daylight Savings Time (DST) cha... | Class II | DePuy Orthopaedics, Inc. |
| Mar 10, 2022 | Merlin PCS 3650 programmer Model 3330 software | Due to a programmer software anomaly under very specific circumstance when executing a pacing cap... | Class II | St. Jude Medical, Cardiac Rhythm Management Div... |
| Mar 10, 2022 | Merlin 2 PCS MER3700 programmer Model MER3400 software | Due to a programmer software anomaly under very specific circumstance when executing a pacing cap... | Class II | St. Jude Medical, Cardiac Rhythm Management Div... |
| Mar 9, 2022 | RocheDiabetes Care Platform Software version 2.5.2 material number 0888835300... | Potential for patient data mismatch when using browser "back" button to navigate between patients... | Class II | Roche Diabetes Care, Inc. |
| Mar 9, 2022 | BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Softwar... | When updating BD Kiestra customers to BD Synapsys version 4.10, the custom antibiotic codes set b... | Class II | Becton Dickinson & Co. |
| Mar 7, 2022 | syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Open Pro Mod... | Upgraded software version makes an automatic change in laser configuration settings for "markerle... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 7, 2022 | syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Sim Model Nu... | Upgraded software version makes an automatic change in laser configuration settings for "markerle... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 7, 2022 | syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number ... | Upgraded software version makes an automatic change in laser configuration settings for "markerle... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 7, 2022 | syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Num... | Upgraded software version makes an automatic change in laser configuration settings for "markerle... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 7, 2022 | SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now ... | Software error may result in sporadic problems causing scanning workflow interruptions, unexpecte... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 4, 2022 | Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. F... | Software issue resulting in temporary loss of central monitoring functionality. | Class II | Draegar Medical Systems, Inc. |
| Feb 28, 2022 | MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the fo... | There is a software anomaly with the InterStim X Clinician software application with results in t... | Class II | Medtronic Neuromodulation |
| Feb 25, 2022 | syngo Application software VE20 (Material Number 10848815) installed on the ... | After CT image data from Toshiba is loaded, image mirroring can occur along the horizontal and ve... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 25, 2022 | Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUE... | Five potential software issues affecting Artis pheno and Artis icono systems in combination with ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 25, 2022 | ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Mon... | The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs. | Class II | Brainlab AG |
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.