CLASS II Device recall · Reported 5 Feb 2014 · FDA Enforcement Report

Radial Assist RAD Board, used to support the weight recalled

Merit Medical Systems is recalling Radial Assist RAD Board, used to support the weight of a patient's arm and supplies for a, distributed in Georgia, Minnesota, New Jersey, Texas, West Virginia. The recall was initiated on 18 Dec 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codeslot B507171

Quantity recalled11

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0901-2014
FDA event ID: 67206
Recalling firm: Merit Medical Systems, South Jordan, UT
Classification: Class II
Status: Terminated
Recall initiated: 18 Dec 2013
FDA classified: 30 Jan 2014
Reported: 5 Feb 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Masks, Gloves & PPE

Timeline

18 Dec 2013	Recall initiated by company
30 Jan 2014	Classified by FDA	+43 days
5 Feb 2014	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

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.

Where it was distributed

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

Georgia Minnesota New Jersey Texas West Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

lot B507171

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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