FDA recall, , Moderate risk
Biomedical Data Solutions Ortho Connect Software
Ortho Connect software can incorrectly reject potential discrepant results during result review and export them to the LIS.
Recall ended Oct 22, 2026. Still check yours.
Summary by Recall Canary from the FDA notice
What happened
Biomedical Data Solutions Limited is recalling distributed units of the ORTHO CONNECT software, software version V3, because the software incorrectly rejects potential discrepant results during the result review process and subsequently exports the results to the LIS. The recall began on February 19, 2026, and was added to the FDA's Enforcement Report on October 22, 2026.
The software was distributed in the US and worldwide, including Thailand, Great Britain, Australia, Switzerland, Bahrain, Canada, Belgium, Italy, Abu Dhabi, Saudia Arabia, Norway, Sweden, Poland, Kuwait, and the Netherlands.
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?
Affected if its model number is listed.
Ortho Connect
- Model number
- 6904413
- 6904414
- 6904415
- 6913355
- 6904410
- 6904411
- 6904412
- 6993333
- 6993332
Recall details
- Company began the recall
- Sold in
US and worldwide (Thailand, Great Britain, Australia, Switzerland, Bahrain, Canada, Belgium, Italy, ABU Dhabi, Saudia Arabia, Norway, Sweden, Poland, Kuwait, Netherlands)
- 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
- 98590
- Recall number
- B-0151-2026
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 · Classified by FDA · Recall ended
Listed on Recall Canary