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 |
|---|---|---|---|---|
| May 31, 2024 | MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a... | 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 - Inended Radiographic X ray Table is a patient table used in... | 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 | MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a... | 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 MD - The Vertix MD Trauma has been specially designed for examin... | 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 |
| Mar 21, 2024 | Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Arti... | Coolant level in the cooling circuit drops below a certain level, this may result in a situation ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 23, 2024 | ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Junipe... | On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or m... | Class II | Siemens Medical Solutions USA, Inc. |
| Feb 23, 2024 | ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select... | On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or m... | Class II | Siemens Medical Solutions USA, Inc. |
| Feb 23, 2024 | ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running softw... | On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or m... | Class II | Siemens Medical Solutions USA, Inc. |
| Nov 29, 2023 | Sensis Vibe Hemo | The possibility of the Sensis documentation functionality application to crash. | Class II | Siemens Medical Solutions USA, Inc |
| Oct 17, 2023 | ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11... | Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 5, 2023 | Mobilett Mira wireless (VA20) mobile x-ray system(s) | Due to the incorrect mounting of the buzzer component, there is no acoustic signal during x ray a... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 12, 2023 | Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed fo... | Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirem... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 12, 2023 | ***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray Sy... | Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirem... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 1, 2023 | (1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNE... | In some cases, when lubricating grease is present within the headband of the over-ear headphones... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 13, 2023 | ACUSON Redwood 2.0 ultrasound systems, REF: 11503314 | If a user-generated preset for an 18L6 transducer created on a 1.0 ultrasound system is used with... | Class II | Siemens Medical Solutions USA, Inc. |
| Jul 12, 2023 | The following Pro.specta Emission Computed Tomography Systems that were manuf... | During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive ... | Class II | Siemens Medical Solutions USA, Inc. |
| Jun 19, 2023 | ARTIS icono biplane -Angiography systems developed for single and biplane dia... | Due to a hardware issue in the cable connectors of the system generator, a thermal overload in th... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 19, 2023 | ARTIS icono floor-Angiography systems developed for single and biplane diagno... | Due to a hardware issue in the cable connectors of the system generator, a thermal overload in th... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 19, 2023 | ARTIS pheno-Angiography systems developed for single and biplane diagnostic i... | Due to a hardware issue in the cable connectors of the system generator, a thermal overload in th... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 5, 2023 | Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operatin... | Incorrect glue was applied on the plexiglass sheet on the single tank cover assembly could potent... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 21, 2023 | ARTIS one with a hybrid cable- An angiography system developed for diagnostic... | Examination room monitor connected with the hybrid cable may have a display issue and no image fu... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 2, 2023 | ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table ... | If, during the procedure, X-ray has been released and a reference image has been stored, the foll... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 2, 2023 | ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET tab... | In the event of any unintended table movement, the system may not detect the incorrect direction,... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 16, 2023 | SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission | This is a potential problem with the locking mechanism that is used to secure the PET gantry in e... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 16, 2023 | SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge | This is a potential problem with the locking mechanism that is used to secure the PET gantry in e... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 16, 2023 | SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3... | This is a potential problem with the locking mechanism that is used to secure the PET gantry in e... | Class II | Siemens Medical Solutions USA, Inc. |
| Dec 22, 2022 | Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow l... | In the syngo.CT VA40 and syngo.CT VA50 myNeedle Guide application, the order of the orientation l... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 21, 2022 | Luminos dRF with software VD10- A diagnostic imaging system for radiographic... | Potential risk of collision with the ceiling, wall, or objects which may result in serious injury... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 21, 2022 | Luminos Agile with software VC10 - A diagnostic imaging system for radiograp... | Potential risk of collision with the ceiling, wall, or objects which may result in serious injury... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 21, 2022 | Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for ... | Potential risk of collision with the ceiling, wall, or objects which may result in serious injury... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 21, 2022 | Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for ... | Potential risk of collision with the ceiling, wall, or objects which may result in serious injury... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 21, 2022 | Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system f... | Potential risk of collision with the ceiling, wall, or objects which may result in serious injury... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 16, 2022 | System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Ar... | In rare cases, the system may only boot into backup mode after an abrupt shutdown and not reach f... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 16, 2022 | ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor | Mechanical connection between the tabletop and table base may be lost. | Class II | Siemens Medical Solutions USA, Inc |
| Dec 9, 2022 | AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF | There is potential for the footrest to detach from the patient table during use. | Class II | Siemens Medical Solutions USA, Inc |
| Dec 9, 2022 | AXIOM Luminos Agile | There is potential for the footrest to detach from the patient table during use. | Class II | Siemens Medical Solutions USA, Inc |
| Dec 9, 2022 | Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max | There is potential for the footrest to detach from the patient table during use. Device intend... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 23, 2022 | LUMINOS Lotus Max (VF11) | Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluoro... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 23, 2022 | Luminos dRF Max (VE10, VF10, VF11) | Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluoro... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 23, 2022 | Luminos Agile Max (VE10, VF10, VF11) | Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluoro... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 16, 2022 | Programmable Diagnostic Computer | The firm will be performing a software update to address a software error which affects the liste... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 9, 2022 | ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3... | When selecting the site fraction group for treatment, the User may select the wrong site for trea... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 20, 2022 | ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000 | Siemens has become aware of three potential software issues with ARTIS pheno systems with softwar... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 10, 2022 | Artis pheno- Model No. 10849000 | Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 10, 2022 | Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis... | Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 10, 2022 | Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700 | Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 12, 2022 | AXIOM Sensis or Sensis Vibe Combo systems as follows: System ... | The Sensis Signal Input Box provides hooks as a milled item on the bottom of the box support the ... | Class III | Siemens Medical Solutions USA, Inc |
| 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 10, 2022 | Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000 | A video signal from one of the transceivers of the Large Display may be lost. In very rare cases,... | 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.