FDA recall, , Moderate risk
Biomedical Data Solutions Complete Ortho Connect 3.x Software
Complete Ortho Connect 3.x Software has an issue with check rules that could lead to an incorrect result being reported or submitted for a patient.
Recall ended Aug 25, 2026. Still check yours.
Summary by Recall Canary from the FDA notice
What happened
Biomedical Data Solutions Limited began a recall of Complete Ortho Connect 3.x Software (Standard License: 1-10 Instruments) ID-MTS, Product Code 6904411, Software Version 3, and Upgrade From Ortho Connect V2.x to Complete Ortho Connect 3.x Software (Standard License: 1-10 Instruments) ID-MTS, Product Code 6904412, Software Version 3.
The company has an issue with check rules that could potentially lead to an incorrect result being reported or submitted for a patient as part of the ORTHO CONNECT medical device middleware. The recall began on April 29, 2025, and the customers in the US are located in IN, MN, TX, SD and CO.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
2 products
Compare these details with yours, then check the recall notice to see which units are recalled.
Upgrade From Ortho Connect V2.x to Complete Ortho Connect 3.x Software (Standard License: 1-10 Instruments) ID-MTS, Product Code 6904412, Software Version 3
Complete Ortho Connect 3.x Software (Standard License: 1-10 Instruments) ID-MTS, Product Code 6904411, Software Version 3
Recall details
- Company began the recall
- Sold in
The customers in the US are located in Indiana, Minnesota, Texas, South Dakota and Colorado.
- Company
- Biomedical Data Solutions Limited
- Hazard
- Software defect
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 97020
- Recall numbers
- B-0029-2026, B-0040-2026
All recalls from Biomedical Data Solutions Limited
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
In FDA's weekly enforcement report
Classified by FDA
Recall ended
Listed on Recall Canary
