Merit Medical Systems, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0901-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 18, 2013

Date Posted: February 5, 2014

Recall Number: Z-0901-2014

Event ID: 67206

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

Status: Terminated

Product Quantity: 11

Code Information:

lot B507171

Distribution Pattern:

Worldwide Distribution - USA including NJ, TX, WV, MN, GA, and Internationally to Mexico and Japan.

Voluntary or Mandated:

Voluntary: Firm initiated