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 |
|---|---|---|---|---|
| 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 |
| Feb 25, 2022 | Artis icono biplane- in combination with a Siemens Healthineers table or Tru... | Five potential software issues affecting Artis pheno and Artis icono systems in combination with ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 25, 2022 | Artis icono floor in combination with a Siemens Healthineers table or Trumpf... | Five potential software issues affecting Artis pheno and Artis icono systems in combination with ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 22, 2022 | Philips Hemodynamic Application, Model Number 722463, Software Version Number... | When a Neonatal patient is admitted, the Non-Invasive Blood Pressure is not set to Neonatal mode ... | Class II | Philips North America Llc |
| Feb 14, 2022 | Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ve... | Cybersecurity Improvement Action-not equipped against potential cyber security threats | Class II | Draeger Medical, Inc. |
| Feb 14, 2022 | Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the vent... | Cybersecurity Improvement Action-not equipped against potential cyber security threats | Class II | Draeger Medical, Inc. |
| Feb 11, 2022 | RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs: RayS... | Incorrect source to skin or surface distance (SSD) calculation may result in dose error when usin... | Class II | RaySearch America Inc |
| Feb 3, 2022 | Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)003807... | Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash b... | Class II | Abbott Laboratories, Inc |
| Feb 2, 2022 | Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029,... | Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the ... | Class II | Philips North America Llc |
| Feb 2, 2022 | Philips StentBoost Live R2.0 application, when used with the Philips Azurion... | Due to an incorrect configuration setting in the EPX database of StentBoost Live, acquisition doe... | Class II | Philips Healthcare |
| Jan 31, 2022 | Ysiosystem with VC10 software version, Model Number 10281013. Radiographic s... | Siemens Healthineers has identified a software error in previous software version VB10 for the Ys... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 28, 2022 | Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI:... | Distribution of Defibrillators that are not approved or cleared for distribution US Market. | Class II | Remote Diagnostic Technologies Ltd. |
| Jan 20, 2022 | The Sight OLO device is a computer vision based platform for blood analysis. ... | In instances where custom reference ranges were configured on the device post installation, a po... | Class II | SIGHT DIAGNOSTICS LTD |
| Jan 19, 2022 | SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software versi... | If FFR measurement(s) are made prior to an iFR/FFR co-registration/pullback in the same procedura... | Class II | Volcano Corporation |
| Jan 14, 2022 | 1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general l... | A software defect in the camera control unit (CCU) will cause the image on the monitor to flip up... | Class II | Stryker Corporation |
| Jan 11, 2022 | CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/... | Retinal analysis system software has some features, based on artificial intelligence, that potent... | Class II | Diagnos Inc |
| Jan 3, 2022 | eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version ... | eCareManager (eCM) Sentry Score software not approved for use | Class II | Philips North America Llc |
| Dec 30, 2021 | RayStation/RayPlan- designed for treatment planning and analysis of radiation... | If a new primary image set is selected while the cine loop is running, the primary image set will... | Class II | RAYSEARCH LABORATORIES AB |
| Dec 20, 2021 | API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualita... | Risk of misidentification or delayed results with the absence of identification due to thermoform... | Class II | Biomerieux Inc |
| Dec 15, 2021 | Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, ... | As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) bei... | Class II | Medtronic Xomed, Inc. |
| Dec 6, 2021 | Alinity m System, Part No. 08N53-002 | There is a software defect that can cause the Amplification Detection clamp CLEAN position to be ... | Class II | Abbott Molecular, Inc. |
| Dec 6, 2021 | Alinity m System, Part No. 08N53-002 | There is a software issue associated with the ability to properly complete a Field Service Engine... | Class II | Abbott Molecular, Inc. |
| Dec 3, 2021 | ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing a... | lmagePilot versions 1.92 and 1.93 paired with an AeroDR or Momentum Panel potential risk of incor... | Class II | Konica Minolta Healthcare Americas, Inc. |
| Dec 2, 2021 | IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neur... | Tile kits that allow one to install and situate a video camera within a patient environment are n... | Class II | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) |
| Nov 29, 2021 | Proteus 235; Version: PTS-8 versions before PTS-8.7.2 | Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) ... | Class II | Ion Beam Applications S.A. |
| Nov 23, 2021 | 1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, mat... | Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo systems with software... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 19, 2021 | SOMATOM Confidence -Computed tomography systems Model 10590100 | Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential ri... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 19, 2021 | Philips Allura Xper FD series with Software Version Number: 2.1.x- intended f... | Set screws securing the two gliding rods of the Extra Monitors (called 7th and 8th monitor) mount... | Class II | Philips North America Llc |
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.