Z-0901-2014Class II

Radial Assist RAD BOARD, used to support the weight of a patient's arm and supplies for a medical procedure...

Name: Z-0901-2014 Radial Assist RAD BOARD, used to support the weight of a patient's arm and supplies for a medical procedure...
Creator: Merit Medical Systems, Inc.
Published: 2013-12-18
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2013-12-18 / Terminated / root cause: labeling and UDI

FDA source

Merit Medical Systems, Inc. began a recall of 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... on 2013-12-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0901-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-18
Posted: 2014-01-30
Terminated: 2014-02-13
Recalling firm: Merit Medical Systems, Inc.
Product: 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 code: BWN Table And Attachments, Operating-Room
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
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Merit Medical Systems, Inc.sent a letter voluntarily recalling one lot (B507171) of RAD BOARD" RB100 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 have been no reports of patient harm or injury from Merit customers as a result of this issue. Merit has chosen to remove this lot from the field by replacing the unlabeled RAD BOARDs. Merit requests that customers stop using these devices immediately until the product has been replaced by their Merit sales representative. Customers with questions were instructed to call 1-801-208-4344 or 1-801-208-4365. For questions regarding this recall call 801-208-4301.
Quantity in commerce: 11
Distribution: Worldwide Distribution - USA including NJ, TX, WV, MN, GA, and Internationally to Mexico and Japan.
Product codes and lots: lot B507171

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0901-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0901-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-30

Product code BWN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)