FDA recall, , Moderate risk
OneBlood Apheresis Red Blood Cells
Apheresis Red Blood Cells were labeled as leukocytes reduced but were not tested to verify white blood cell count.
Recall ended Jun 29, 2026. Still check yours.
Summary by Recall Canary from the FDA notice
What happened
OneBlood, Inc. recalled Apheresis Red Blood Cells, Irradiated and Apheresis Red Blood Cells, Leukocytes Reduced because they were labeled as leukocytes reduced but were not tested to verify white blood cell count. The recall began June 24, 2025, and was added to the FDA's Enforcement Report on June 29, 2026. The products were distributed in Florida.
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.
Apheresis Red Blood Cells, Irradiated
Reason: Apheresis Red Blood Cells, Irradiated, which were labeled as leukocytes reduced but were not tested to verify white blood cell count, were distributed.
Apheresis Red Blood Cells, Leukocytes Reduced
Reason: Apheresis Red Blood Cells, Leukocytes Reduced, which were labeled as leukocytes reduced but were not tested to verify white blood cell count, were distributed.
- Affected units
- W036825127956 (double collection); W036825488218 (double collection); W036825488220; W036825488463 (double collection); W036825488474 (double collection)
Recall details
- Company began the recall
- Sold in
- Company
- OneBlood, Inc.
- Hazard
- Quality testing problem
- 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
- 99103
- Recall numbers
- B-0101-2026 to B-0102-2026
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
