Use caution Medical device recall · FDA · Published October 16, 2020

Ra Medical Systems DABRA Laser Recall: Footswitch Liquid Spill Risk

Ra Medical Systems recalls DABRA RA-308 Excimer Laser units with footswitch that may fail if liquids spill, risking unintended laser activation during vascular procedures.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0569-2021Medical device Ra Medical Systems ›

Use caution until it’s fixed

Due to footswitch not meeting required specification for protection from ingress of solids or liquids. If spilling of liquids near or on the footswitch, it may fail in the 'on' position and allow the laser to continue to lase.

Take action

Contact the company

Recalling firmRa Medical Systems, Inc.2070 Las Palmas Dr · Carlsbad, CA 92011-1518

✎ GovInfoNow plain-language explainer

Ra Medical Systems is recalling DABRA Laser (RA-308 Excimer Laser) units because the footswitch may fail if liquids spill near it, potentially causing the laser to activate unexpectedly during medical procedures. This could lead to unintended tissue damage if the laser operates without proper control. Read more at govinfonow.com/recall/64087-ra-medical-systems-dabra-laser-recall-footswitch-liquid-spill-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/64087-ra-medical-systems-dabra-laser-recall-footswitch-liquid-spill-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0569-2021

Cite this page

“Ra Medical Systems DABRA Laser Recall: Footswitch Liquid Spill Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64087-ra-medical-systems-dabra-laser-recall-footswitch-liquid-spill-risk. Based on FDA recall #Z-0569-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0569-2021%22&limit=1).

Ra Medical Systems, Inc. voluntarily recalled the DABRA Laser (RA-308 Excimer Laser) due to a footswitch hazard that could allow the laser to continue firing if liquids spill on it, according to the FDA. The agency announced the Class II recall on Oct. 16, 2020.

How to tell if you have it

Brand: Ra Medical Systems
Product: DABRA Laser (RA-308 Excimer Laser)
Model Number: RA-308
Catalog Number: 1200-0001-01
Serial Numbers: RA00027, RA00046, RA00049, RA00050, RA00054, RA00056, RA00057, RA00058, RA00064, RA00069, RA00073, RA00081, RA00083, RA00084, RA00085, RA00089, RA00097, RA00098, RA00114, RA00115, RA00120, RA00121, RA00125, RA00127, RA00135, RA00138, RA00148, RA00153, RA00154, RA00160, RA00164, RA00165, RA00167, RA00170, RA00175, and RA00177
Quantity: 36 devices
Distribution: Sold in AL, AZ, CA, FL, IL, IN, KY, LA, MD, NC, NV, NY, OK, OR, TX, WA, and Japan

The hazard

The footswitch does not meet required specifications for protection from ingress of solids or liquids. If liquids spill near or on the footswitch, it may fail in the 'on' position and allow the laser to continue to lase.

Context

GovInfoNow's records show Ra Medical Systems, Inc. has had five other recalls since Feb. 15, 2018. Other recent recalls of similar products include Lutronic DermaV Laser System Recall (Aug. 6, 2026), Lutronic CLARITY II Laser System Model 1110200210 Sparks and May Burn Patients (Jan. 27, 2026), and Arrow Medical Drainage Kits Recall (April 21, 2026).

How to tell if you have this one

Check for serial numbers listed: RA00027, RA00046, RA00049, RA00050, RA00054, RA00056, RA00057, RA00058, RA00064, RA00069, RA00073, RA00081, RA00083, RA00084, RA00085, RA00089, RA00097, RA00098, RA00114, RA00115, RA00120, RA00121, RA00125, RA00127, RA00135, RA00138, RA00148, RA00153, RA00154, RA00160, RA00164, RA00165, RA00167, RA00170, RA00175, and RA00177.

Brand
Ra Medical Systems
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Footswitch for Spills
Inspect the footswitch for signs of liquid exposure or damage, as this could cause the laser to activate unexpectedly.

Where it went and when

Where it was distributed

Distributed in 16 states, and outside the U.S.

FDA distribution: “US Distribution to states of: AL, AZ, CA, FL, IL, IN, KY, LA, MD, NC, NV, NY, OK, OR, TX, and WA; and to OUS country: Japan.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, California, Florida, Illinois, Indiana, Kentucky, Louisiana, Maryland, Nevada, New York, North Carolina, Oklahoma, Oregon, Texas, Washington.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

Oct 16, 2020Firm started the recall
Dec 14, 2020FDA classified it Class II
Dec 23, 2020Published in FDA’s Enforcement Report
Jan 11, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/64087-ra-medical-systems-dabra-laser-recall-footswitch-liquid-spill-risk">Ra Medical Systems DABRA Laser Recall: Footswitch Liquid Spill Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0569-2021 (October 16, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0569-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.