Radial Assist RAD BOARD, used to support the weight of a patient's arm and supplies for a medica...
FDA Device Recall #Z-0901-2014 — Class II — December 18, 2013
Recall Summary
| Recall Number | Z-0901-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 18, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Merit Medical Systems, Inc. |
| Location | South Jordan, UT |
| Product Type | Devices |
| Quantity | 11 |
Product Description
Radial Assist RAD BOARD, used to support the weight of a patient's arm and supplies for a medical procedure. The Merit RAD BOARD is a rigid and stiff body board intended for use for various medical purposes. RAD BOARD was specifically designed to support the weight of a patient's arm and supplies for medical procedure, in order to have optimal access to upper extremity vasculature, including radial and brachial arterial and venous access. The RAD BOARD is partially lined with a layer of lead-free Xenolite TB for additional radiation scatter protection.
Reason for Recall
Merit Medical Systems, Inc. is voluntarily recalling one lot (B507171) of RAD BOARD RB 100 devices. The affected devices are missing the main label which graphically depicts patient orientation on the board. The issue may allow the board to be oriented in the wrong direction where the semi-radiopaque material in the board (embedded Xenolite) could obscure patient anatomy during fluoroscopy. There
Distribution Pattern
Worldwide Distribution - USA including NJ, TX, WV, MN, GA, and Internationally to Mexico and Japan.
Lot / Code Information
lot B507171
Other Recalls from Merit Medical Systems, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2003-2026 | Class II | Philips Bridge Prep Kit REF: K12-09098C Steri... | Apr 2, 2026 |
| Z-2002-2026 | Class II | Philips Bridge Prep Kit REF: K12-09098B Steri... | Apr 2, 2026 |
| Z-2004-2026 | Class II | Philips Bridge Prep Kit REF: K12-09098C Steri... | Apr 2, 2026 |
| Z-1578-2026 | Class I | DuraMax Chronic Hemodialysis Catheter, REF: H78... | Feb 13, 2026 |
| Z-1576-2026 | Class I | ProGuide Chronic Dialysis Catheters, REF: DC014... | Feb 13, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.