Blue Ortho recalls
Every recall we track for Blue Ortho — 3 in all, from 2019–2024 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
3 recalls since 2017.
All FDA recall records for Blue Ortho since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 1 | 0 | 1 |
| 2020 | 0 | 0 | 1 | 0 | 1 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 1 | 1 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Blue Ortho product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Blue Ortho recalls
3 shown- UnratedMedical device
Blue Ortho recalls Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of
Blue Ortho recalls Predict+ software for shoulder surgery decision support due to lack of pre-market clearance. Users should check software version v1.3 for affected units.
Blue OrthoAug 30, 2024 - Lower riskMedical device
Blue Ortho recalls Instructions For Use document of the GPS Trackers.
Blue Ortho recalls specific GPS Tracker models (A100003, A100004, A100005, A100006) due to potential language issues in reprocessing instructions. Affected units have listed serial numbers.
Blue OrthoSep 10, 2020 - Lower riskMedical device
Blue Ortho recalls Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee
Blue Ortho recalls TKA Pro v2.1 software for Exactech GPS knee surgery systems due to incorrect navigated values. Affected users should contact Blue Ortho for updates.
Blue OrthoSep 22, 2019
Blue Ortho recall questions
How many recalls has Blue Ortho had?
3 recalls from Blue Ortho are on record with U.S. safety agencies, from 2019–2024.
What is the most recent Blue Ortho recall?
Blue Ortho recalls Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of, dated Aug 30, 2024. Every Blue Ortho recall is listed on this page, newest first.
What should I do if I have a recalled Blue Ortho product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Blue Ortho recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.