Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter Recalled by Northgate Technologies, Inc. Due to The languages for Russian, Romanian, Slovak, and Czech...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Northgate Technologies, Inc. directly.
Affected Products
Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be used with Northgate Technologies Inc. bipolar disposable EHL probes for the fragmentation of calculi.
Quantity: 2,277 devices
Why Was This Recalled?
The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device.
Where Was This Sold?
This product was distributed to 1 state: MA
About Northgate Technologies, Inc.
Northgate Technologies, Inc. has 9 total recalls tracked by RecallDetector.
Related Recalls
EndoVive Safety PEG Kit Recalled by Boston Scientific Corporation Due to Recall of kits which utilized ChloraPrep Triple Swabsticks...
Boston Scientific Corporation · February 10, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Artelon FlexBand Dynamic Matrix Ref: 31057 Recalled by International Life Sciences Due to Augmentation devices failed bacterial endotoxin testing.
International Life Sciences · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Data sourced from the FDA (Device). Last updated March 26, 2026. View original report