Boston Scientific Corporation EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
Serial Numbers: 2005201213 2005201287 2005201346 GTIN: 08714729990901
Products Sold
Serial Numbers: 2005201213 2005201287 2005201346 GTIN: 08714729990901
Boston Scientific Corporation is recalling EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic due to May have been programmed with a less than optimal brightness setting resulting in a darker than desired image. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
May have been programmed with a less than optimal brightness setting resulting in a darker than desired image
Recommended Action
Per FDA guidance
Boston Scientific issued Medical Device Removal - Immediate Action Required letter on 3/16/21. Letter states reason for recall, health risk and action to take: While no adverse health consequences are anticipated and an impacted Controller can continue to be used, replacement of the Controller is advised for optimal image quality. A Boston Scientific representative will be in contact with you directly to schedule installation of a replacement Controller at your facility. If you notice a darker than desired image, manually adjust the brightness setting on the front of the EXALT" Controller to the High setting (all five bars on the Brightness Indicator illuminated) A Boston Scientific representative will be in contact with you directly to schedule the installation of a replacement Controller at your facility. Your current Controller will be removed at that time. Please read carefully through the enclosed instructions. We ask that you please confirm receipt of this notification by completing the enclosed Acknowledgement Form and sending it to BSCFieldActionCenter@bsci.com or fax to 763-415-7708.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026