Browse Device Recalls

702 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 702 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 702 FDA device recalls.

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DateProductReasonClassFirm
Dec 29, 2025 Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Materia... Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring si... Class II Siemens Medical Solutions USA, Inc
Dec 29, 2025 Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Materia... Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring si... Class II Siemens Medical Solutions USA, Inc
Dec 19, 2025 NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification ... To remove the software applications from certain CT systems as the applications have not received... Class II Siemens Medical Solutions USA, Inc
Dec 19, 2025 NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.... To remove the software applications from certain CT systems as the applications have not received... Class II Siemens Medical Solutions USA, Inc
Dec 19, 2025 SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo... To remove the software applications from certain CT systems as the applications have not received... Class II Siemens Medical Solutions USA, Inc
Dec 19, 2025 NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification sy... To remove the software applications from certain CT systems as the applications have not received... Class II Siemens Medical Solutions USA, Inc
Dec 5, 2025 LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471 A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software ve... Class II Siemens Medical Solutions USA, Inc
Oct 24, 2025 MAMMOMAT Revelation; There were instances where the operator table was sold together with a bus-installation kit. The ... Class II Siemens Medical Solutions USA, Inc
Oct 24, 2025 MAMMOMAT Fusion; There were instances where the operator table was sold together with a bus-installation kit. The ... Class II Siemens Medical Solutions USA, Inc
Oct 24, 2025 MAMMOMAT Inspiration; There were instances where the operator table was sold together with a bus-installation kit. The ... Class II Siemens Medical Solutions USA, Inc
Oct 1, 2025 MAGNETOM Cima.X Upgrade. Model Number: 11689304. There is a potential for an ice blockage to form or currently exist within the primary and/or the... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Verio Dot. Model Number: 10684333. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 BIOGRAPH One (DE). Model Number: 11689172. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Prisma. Model Number: 10849582. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Connectom.X. Model Number: 11371480. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Verio Dot Upgrade. Model Number: 10684334. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Cima.X (DE). Model Number: 11647158. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Skyra fit. Model Number: 10849580. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Vida Fit. Model Number: 11410481. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K... There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837... There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Lumina (DE). Model Number: 11344916. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Verio. Model Number: 10276755. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 Biograph mMR. Model Number: 10433372. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111... There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 12, 2025 Artis Pheno. Image-Intensified Flouroscopic X-Ray System. Limited system movements after startup . Class II Siemens Medical Solutions USA, Inc
Jun 4, 2025 UROSKOP Omnia. Model Number: 10094910 A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housi... Class II Siemens Medical Solutions USA, Inc
Jun 4, 2025 UROSKOP Omnia Max. Model Number: 10762473 A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housi... Class II Siemens Medical Solutions USA, Inc
May 15, 2025 ARTIS is a family of dedicated angiography systems developed for single and ... In very rare situations, communication between the sensor measuring dose applied to the area and ... Class II Siemens Medical Solutions USA, Inc
May 15, 2025 interventional fluoroscopic x-ray system In very rare situations, communication between the sensor measuring dose applied to the area and ... Class II Siemens Medical Solutions USA, Inc
May 15, 2025 interventional fluoroscopic x-ray system In very rare situations, communication between the sensor measuring dose applied to the area and ... Class II Siemens Medical Solutions USA, Inc
May 15, 2025 interventional fluoroscopic x-ray system In very rare situations, communication between the sensor measuring dose applied to the area and ... Class II Siemens Medical Solutions USA, Inc
Jan 2, 2025 ARTIS One Angiographic X-Ray System A potential issue with ARTIS One systems was identified. In very rare situations, the first x-ra... Class II SIEMENS MEDICAL SOLUTIONS USA, INC
Aug 15, 2024 ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with... If ultrasound systems with software, are changed from factory default to : 1) Milliliters per sec... Class II Siemens Medical Solutions USA, Inc.
Aug 15, 2024 ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ... If ultrasound systems with software, are changed from factory default to : 1) Milliliters per sec... Class II Siemens Medical Solutions USA, Inc.
Aug 15, 2024 ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 1133579... If ultrasound systems with software, are changed from factory default to : 1) Milliliters per sec... Class II Siemens Medical Solutions USA, Inc.
Jul 3, 2024 Sensis Vibe systems with software version VD15B-Intended to be used as a diag... If the Sensis documentation functionality is used during adding of once-per-study reporting event... Class II Siemens Medical Solutions USA, Inc
Jul 3, 2024 Sensis Vibe systems with software version VD15B in combination with AXIOM Se... If the Sensis documentation functionality is used during adding of once-per-study reporting event... Class II Siemens Medical Solutions USA, Inc
Jul 3, 2024 Sensis Vibe systems with software version VD15B in combination with VM VIRTUA... If the Sensis documentation functionality is used during adding of once-per-study reporting event... Class II Siemens Medical Solutions USA, Inc
Jul 3, 2024 Sensis Vibe systems with software version VD15B in combination with Sensis Hi... If the Sensis documentation functionality is used during adding of once-per-study reporting event... Class II Siemens Medical Solutions USA, Inc
Jul 2, 2024 Multitom Rax -Intended to visualize anatomical structures by converting an x-... The support arm may unintentionally lower resulting in injury to persons when they are under the ... Class II Siemens Medical Solutions USA, Inc
Jul 2, 2024 Luminos dRF Max- Intended to visualize anatomical structures by converting an... The support arm may unintentionally lower resulting in injury to persons when they are under the ... Class II Siemens Medical Solutions USA, Inc
Jul 2, 2024 Luminos Agile Max -Intended to visualize anatomical structures by converting ... The support arm may unintentionally lower resulting in injury to persons when they are under the ... Class II Siemens Medical Solutions USA, Inc
Jul 2, 2024 LUMINOS Lotus Max -Intended to visualize anatomical structures by converting ... The support arm may unintentionally lower resulting in injury to persons when they are under the ... Class II Siemens Medical Solutions USA, Inc
May 31, 2024 ZE for Vertix Solitaire - The AXIOM Vertix Solitaire is a component and has b... Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire Class II Siemens Medical Solutions USA, Inc
May 31, 2024 AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used i... Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire Class II Siemens Medical Solutions USA, Inc
May 31, 2024 AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used i... Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire Class II Siemens Medical Solutions USA, Inc
May 31, 2024 AXIOM Vertix Solitaire - The Vertix MD Trauma has been specially designed for... Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire Class II Siemens Medical Solutions USA, Inc
May 31, 2024 AXIOM MULTIX MP - Intended Radiographic X ray Table is a patient table used i... Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire Class II Siemens Medical Solutions USA, 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.