Class II — Blue Ortho
| Recalling firm | BLUE ORTHO |
|---|---|
| Registered facility | BLUE ORTHO (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | Instructions For Use document of the GPS Trackers. |
| Quantity | 3471 units |
| Distribution | Domestic Distribution Only: CA, CO, SC and WI. |
| Initiated | 2020-09-10 |
| Classified | 2020-10-23 |
| Terminated | 2023-05-31 |
| Recall number | Z-0288-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Blue Ortho (Z-0288-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86491/
Alerts for BLUE ORTHO
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.