Table And Attachments, Operating-Room
FDA adverse event reports and recall history for table and attachments, operating-room (product code BWN), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 225
- Deaths
- 1
- Injuries
- 60
- Malfunctions
- 141
Reports per year
Source: FDA adverse event reports by year received, 2009–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2026-10-02Open, ClassifiedDevice Design
Brand Name: ADAPTABLE Beach Chair Product Name: Beach Chair surgical patient positioner Model/Catalog Number: 804-33-300 (Enovis); 3105-400-030 (Stryker); internal BC-0001 / BC-0220 Software Version: N/A Product Description: Surgical beach-chair positioner that mounts to the accessory rails of the OR table leg section to elevate and support the patient's upper body in the upright (beach chair) position during surgical procedures. Component: No, finished device. The failure is in the BC-0105, subcomponent.
Due to a manufacturing issue (inadequate weld) for patient head positioning system.
- 2014-01-30TerminatedLabeling Change Control
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.
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
- TerminatedDevice Design
ARCH Leg Positioning System
Due to the holes not being bored to the specific diameter, the locking pins are unable to engage under a load.
- TerminatedUnder Investigation by firm
7.2cm Adjustable Drill Guide Product Usage: Electric system
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- TerminatedUnder Investigation by firm
19CM ATTACHMENT, BLACK MAX
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- TerminatedUnder Investigation by firm
11.25CM ATTACHMENT, BLACK MAX
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- TerminatedUnder Investigation by firm
LARGE CRANIOTOME, BLACK MAX
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- TerminatedUnder Investigation by firm
STANDARD CRANIOTOME, BLACK MAX
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- TerminatedUnder Investigation by firm
GREEN ROTATING CRANIOTOME, BLACK MAX
Supplied Directions for Use (DFU) did not contain a recommended service interval.
- TerminatedUnder Investigation by firm
ADJUSTABLE DRILL GUIDE, BLACK MAX
Supplied Directions for Use (DFU) did not contain a recommended service interval.
Monitor table and attachments, operating-room automatically
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