FDA recall, , Moderate risk
OneBlood Apheresis Red Blood Cells, Leukocytes Reduced
Apheresis Red Blood Cells, Leukocytes Reduced were labeled as leukocytes reduced but failed the monthly QC residual white blood cell count.
Recall ended Jun 26, 2026. Still check yours.
Summary by Recall Canary from the FDA notice
What happened
OneBlood, Inc. recalled Apheresis Red Blood Cells, Leukocytes Reduced because the product was labeled as leukocytes reduced but failed the monthly QC residual white blood cell count. The recall began May 1, 2025, and was added to the FDA's Enforcement Report on June 26, 2026, with distribution in Pennsylvania.
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?
Compare these details with yours, then check the recall notice to see which units are recalled.
Apheresis Red Blood Cells, Leukocytes Reduced
Recall details
- Company began the recall
- Sold in
- Company
- OneBlood, Inc.
- Hazard
- Labeling error
- 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
- 99091
- Recall number
- B-0085-2026
All recalls from OneBlood, Inc.
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
In FDA's weekly enforcement report
Listed on Recall Canary
Archived
