Browse Device Recalls
30 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 30 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 30 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 12, 2025 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography a... | Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... | Class II | UIH Technologies LLC |
| Sep 12, 2025 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray Syst... | Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... | Class II | UIH Technologies LLC |
| Sep 12, 2025 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography a... | Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... | Class II | UIH Technologies LLC |
| Sep 12, 2025 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray Syst... | Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... | Class II | UIH Technologies LLC |
| Sep 12, 2025 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray Syst... | Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... | Class II | UIH Technologies LLC |
| Sep 12, 2025 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray Syst... | Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... | Class II | UIH Technologies LLC |
| Sep 12, 2025 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography a... | Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... | Class II | UIH Technologies LLC |
| Sep 12, 2025 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography a... | Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... | Class II | UIH Technologies LLC |
| Sep 12, 2025 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray Syst... | Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... | Class II | UIH Technologies LLC |
| Mar 1, 2023 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PE... | Due to a software issue where the process of patient scanning, the scatter correction may occasio... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| May 30, 2022 | Positron Emission Tomography and Computed Tomography System, Model: uMI 550 | The wireless VSM module of a mobile PET/CT system, operating in an environment with strong Wi-Fi ... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Aug 2, 2021 | uMI 550 System - Product Usage: intended to be operated by qualified healthca... | The EXAM acquisition workflow could occasionally freeze after canceling the PET scan. | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Aug 2, 2021 | uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified... | The EXAM acquisition workflow could occasionally freeze after canceling the PET scan. | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Jan 25, 2021 | Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01)... | There is a potential for the X-Ray tube head (Touch screen interface) to perform an uncommanded ... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Aug 5, 2020 | Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 0697157683101... | A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Displ... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Aug 5, 2020 | Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 0697157683103... | A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Displ... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Aug 5, 2020 | Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 0697157683104... | A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Displ... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Aug 5, 2020 | Positron Emission Tomography and Computed Tomography System, Model uMI 550, R... | A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Displ... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Jul 16, 2020 | uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is inte... | 1) Service function problem may cause false marking of a bad channel resulting in ring artifacts;... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Jul 16, 2020 | uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is in... | 1) 1) Potential intermittent issue may cause image data problems, may lead to artifacts; 2) Poten... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Jun 20, 2020 | Computed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 0697157... | The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge. | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Jun 20, 2020 | Computed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 0697157... | The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge. | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Jun 20, 2020 | Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 0697157... | The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge. | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| May 23, 2020 | Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 In... | Two issues were identified with the computed tomography x-ray system including a service function... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| May 8, 2020 | uCT 530 Computed Tomography X-Ray System | Two issues were identified with the computed tomography x-ray system including a service function... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| May 8, 2020 | uCT 760 System, Computed Tomography X-ray System | Two issues were identified with the computed tomography x-ray system including an intermittent i... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Mar 26, 2020 | Positron Emission Tomography and Computed Tomography System, Model: uMI 550, ... | In affected software version, of Positron emission tomography and computed tomography system, the... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Feb 27, 2020 | uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to u... | Two issues were identified with the stationary x-ray system. 1. Some position illustrations in th... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Aug 26, 2019 | Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, w... | Potential sporadic software bugs in R001.3.0.0.750505 software version may cause an issue with th... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Jul 30, 2019 | Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h | X-ray imaging system positioning image and protocol label is reversed for Flexion and Extension o... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
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.