Northgate Technologies recalls AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe due to incorrect labeling. This affects specific model numbers and lot codes.
📍Recalling firmNorthgate Technologies, Inc.1591 Scottsdale Ct · Elgin, IL 60123-9361
✎ GovInfoNow plain-language explainer
Northgate Technologies is recalling their AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe because it was labeled incorrectly. This labeling issue means users might not know if they have the recalled model, which could lead to improper use or confusion. Read more at govinfonow.com/recall/60816-northgate-autolith-touch-1-product-labeled-incorrectly.
“Northgate AUTOLITH Touch 1.: Product Labeled Incorrectly.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60816-northgate-autolith-touch-1-product-labeled-incorrectly. Based on FDA recall #Z-1235-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1235-2022%22&limit=1).
The FDA announced on April 13, 2022, that Northgate Technologies, Inc. is recalling the AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe because it was labeled incorrectly.
The product was labeled incorrectly, according to the FDA.
Context
GovInfoNow's records show Northgate Technologies, Inc. has 3 other recalls on record since 2020-03-10. On 2021-10-25, the company recalled the Northgate Boston Scientific AUTOLITH TOUCH Lithotripter due to language settings issues. Other recent recalls of similar products include W L Gore GORE VIABIL Short Wire Biliary Endoprosthesis Recall (2026-05-22), Medline TRACH TUBE KIT Recall (2026-07-10), and Orthof: MINIRAIL Fixation Devices May Be Mislabeled - Recall (2026-06-10).
How to tell if you have this one
Check for the model number 1.9F 375cm, NTI Catalog Number 72-00322-0, or BSC Catalog No. M00546620. Also look for the lot code BSC15876 or GTIN 00817183020448.
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-1235-2022 (April 13, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1235-2022 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.
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