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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.