Browse Device Recalls
23 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 23 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 23 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 9, 2026 | FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 5... | It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X... | Class II | FUJIFILM Healthcare Americas Corporation |
| Sep 15, 2025 | FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566... | It was found that the shaft for mounting the X-ray tube unit on the support may break. In additio... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jun 11, 2025 | ASPRIRE Cristalle Mammography System (cleared under K212873) installed with t... | Devices had an unapproved slabbing software function enabled for use. | Class II | FUJIFILM Healthcare Americas Corporation |
| Feb 11, 2025 | Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4... | The incorrect computed patient age is showing in VX for patients less than 3 months old. | Class II | FUJIFILM Healthcare Americas Corporation |
| Apr 11, 2024 | Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM... | AC adapters of Noblus can heat up, and cause smoke in the worst case, when an excessive mechanica... | Class II | FUJIFILM Healthcare Americas Corporation |
| Apr 11, 2024 | FDR Visionary Suite - Intended to generate digital or conventional radiograph... | Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, co... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 10, 2024 | Synapse PACS - Version 7.2.200 | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM heade... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 10, 2024 | Synapse PACS - Version 7.3.000 | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM heade... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 10, 2024 | Synapse PACS - Version 7.1.000US | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM heade... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 10, 2024 | Synapse PACS - Version 7.2.000 | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM heade... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 10, 2024 | Synapse PACS - Version 7.1.000 | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM heade... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 10, 2024 | Synapse PACS - Version 7.2.100 | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM heade... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 3, 2024 | Synapse CV 6. with AR. A web-based application as the primary user interfa... | The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the ma... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 3, 2024 | Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application a... | The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the ma... | Class II | FUJIFILM Healthcare Americas Corporation |
| Nov 23, 2023 | The device is a mobile x-ray system designed to work with Fujifilm's GOS and ... | When the key switch is turned on, the exposure conditions are set to the default values (85kV, 1.... | Class II | FUJIFILM Healthcare Americas Corporation |
| Feb 27, 2023 | FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended f... | Arm which holds the tube head in place is susceptible to breaking, if the device breaks it could ... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jul 12, 2022 | Surpria: Software Version V3.11, V3.22 | Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstruc... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jul 12, 2022 | SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C | Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstruc... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jul 12, 2022 | Surpria 64: Software Version V3.11, V3.22 | Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstruc... | Class II | FUJIFILM Healthcare Americas Corporation |
| Oct 14, 2021 | Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0 | When the ultrasound system is used in combination with a Fujifilm (formally Hitachi) transducer, ... | Class II | FujiFilm Healthcare Americas Corporation |
| Oct 14, 2021 | Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3 | Diagnostic ultrasound system with the specified software version and used in conjunction with a F... | Class II | FujiFilm Healthcare Americas Corporation |
| Oct 14, 2021 | Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3 | Diagnostic ultrasound system with the specified software version and used in conjunction with a F... | Class II | FujiFilm Healthcare Americas Corporation |
| Oct 14, 2021 | Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3 | Diagnostic ultrasound system with the specified software version and used in conjunction with a F... | Class II | FujiFilm Healthcare Americas Corporation |
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.