Browse Device Recalls
9 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 9 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 9 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 5, 2025 | Brand Name: Branding is not applied to this product. Product Name: DVI displ... | Due to display cables used for monitors were not in compliance with electromagnetic interference ... | Class II | Spacelabs Healthcare, Inc. |
| Sep 5, 2025 | Brand Name: Branding is not applied to this product. Product Name: DVI displ... | Due to display cables used for monitors were not in compliance with electromagnetic interference ... | Class II | Spacelabs Healthcare, Inc. |
| Sep 5, 2025 | Brand Name: Branding is not applied to this product. Product Name: DVI displ... | Due to display cables used for monitors were not in compliance with electromagnetic interference ... | Class II | Spacelabs Healthcare, Inc. |
| Nov 25, 2024 | Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide mo... | Telemetry receivers with affected software versions may experience unsolicited system shut down a... | Class II | Spacelabs Healthcare, Inc. |
| Nov 25, 2024 | Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to pr... | Telemetry receiver systems may experience a Windows proxy Issue causing the system to shut down a... | Class II | Spacelabs Healthcare, Inc. |
| Apr 12, 2023 | Ultraview SL (UVSL) Command Module, Model 91496 | Command modules will display the following when parameter processing is suspended, depending on s... | Class II | Spacelabs Healthcare, Inc. |
| May 31, 2022 | Xhibit Telemetry Receiver, Model: 96280 | Software related alarm escalation defect occurs after approximately 25 days of continuous use. Te... | Class II | Spacelabs Healthcare, Inc. |
| Aug 30, 2019 | Xhibit Central, Model No. 96102 - Product Usage: intended use is to provide c... | The firm received reports of loss of audio alarm after a power failure or cable disconnection. Th... | Class II | Spacelabs Healthcare, Inc. |
| Jan 28, 2019 | Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the... | Several reports were received that patient records were printed with the correct patient demograp... | Class II | Spacelabs Healthcare, 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.