Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Instructions For Use document of the GPS Trackers. Recalled by Blue Ortho Due to Appropriateness of the language used in the Tracker...
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 Blue Ortho directly.
Affected Products
Instructions For Use document of the GPS Trackers.
Quantity: 3471 units
Why Was This Recalled?
Appropriateness of the language used in the Tracker reprocessing instruction. Reason is that some Low Temperature sterilization conditions mentioned in the IFUs are approved based on rational documents.
Where Was This Sold?
This product was distributed to 4 states: CA, CO, SC, WI
About Blue Ortho
Blue Ortho has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report