Lower riskMedical device recall · FDA · Published March 16, 2021
Boston Scientific EXALT Controller Recall: Darker Image Settings Risk
Boston Scientific recalls EXALT Controller devices with potential darker image settings for endoscopic procedures. Affected units have specific serial numbers and were sold with endoscopes for diagnosis.
“Boston Scientific EXALT Controller Recall: Darker Image Settings Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63070-boston-scientific-exalt-controller-recall-darker-image-settings-risk. Based on FDA recall #Z-1492-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1492-2021%22&limit=1).
The FDA announced on March 16, 2021, that Boston Scientific Corporation voluntarily recalled the EXALT Controller due to a potential programming error. The device may display a darker than desired image during endoscopic diagnosis. This Class III recall affected three units distributed in California, Florida, and New Jersey.
How to tell if you have it
Brand: Boston Scientific
Product: EXALT Controller
UPC: 08714729990901
Distribution: CA, FL, NJ
The hazard
The recalled controllers may have been programmed with a less than optimal brightness setting. This error results in a darker image than desired for the user.
Context
GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since June 1, 2017. Recent recalls include the Imager II Angiographic Catheters Recall (August 24, 2026) and the LUX-Dx Cardiac Monitor System Recall (August 6, 2026). Other recent recalls of similar products include the Siemens LUMINOS Q.namix T X-Ray System Recall (December 29, 2025), the Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall (March 3, 2026), and the Philips MultiDiagnost Eleva Recall (May 18, 2026).
How to tell if you have this one
Check for serial numbers 2005201213, 2005201287, or 2005201346 on the EXALT Controller. These devices were sold with Boston Scientific endoscopes for medical procedures.
Brand
Boston Scientific
Product
EXALT Controller
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Serial Number
Look for serial numbers 2005201213, 2005201287, or 2005201346 on the EXALT Controller.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of CA, FL, NJ.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, New Jersey.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1492-2021 (March 16, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1492-2021 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.