Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
AUTOLITH URO-TCH 9FR PROBE 54CM Recalled by Northgate Technologies, Inc. Due to Investigation into a biocompatibility test discrepancy where a...
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
AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
Quantity: 198 boxes. 3 units per box.
Why Was This Recalled?
Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Northgate Technologies, Inc.
Northgate Technologies, Inc. has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report