FDA recall, , Moderate risk
WellSky Transfusion Blood-Bank Management System
The blood-bank management system can fail to present a required alert, which could permit transfusion of incompatible blood.
Recall ended Apr 16, 2026. Still check yours.
Summary by Recall Canary from the FDA notice
What happened
WellSky Corporation recalled the WellSky Transfusion standalone blood-bank management system versions 2023 R1.0.37 and 2025 R1.0.5 because the system can fail to present the required soft-stop alert when antigen-positive RBC units are issued to patients with a corresponding level-3 antibody if the Test Required flag is left unchecked.
The recall began June 9, 2025, and was added to the FDA's Enforcement Report on March 24, 2026. The product was distributed in Houston, Texas; Jacksonville, Florida; Buffalo, New York; and Bethlehem, Pennsylvania, as well as Toronto, Ontario, Canada.
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 UPC is listed.
A UPC is the number printed under a barcode.
WellSky Transfusion standalone blood-bank management system versions 2023 R1.0.37 and 2025 R1.0.5
- UPC
- B105TRANSFUSION20230
- 7150WELLSKYH
Recall details
- Company began the recall
- Sold in
Distributed in the US: Houston Texas, Jacksonville Florida, Buffalo New York, and Bethlehem Pennsylvania. Distributed in Canada: Toronto Ontario
- Company
- WellSky Corporation
- 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
- 97134
- Recall number
- B-0028-2026
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
In FDA's weekly enforcement report
Recall ended
Listed on Recall Canary
Archived
