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FDA recall, , Moderate risk

Blood Assurance Pooled Cryoprecipitated AHF and Red Blood Cells

Pooled Cryoprecipitated AHF and Red Blood Cells, Leukocytes Reduced were collected from a donor at increased risk for Creutzfeldt-Jakob Disease.

Recall ended Aug 7, 2026. Still check yours.

What happened

Blood Assurance Inc began a recall on January 1, 2026, of Red Blood Cells, Leukocytes Reduced and Pooled Cryoprecipitated AHF, collected from a donor who had received a dura mater graft and was at increased risk for Creutzfeldt-Jakob Disease (CJD). The products were distributed in Georgia and Tennessee. The FDA added the recall to its Enforcement Report and classified it on August 7, 2026, with the recall in the weekly enforcement report on August 19, 2026.

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:

  1. Check the FDA or company notice for instructions specific to this product.
  2. 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.

  1. Red Blood Cells, Leukocytes Reduced

    Reason: Red Blood Cells, Leukocytes Reduced, collected from a donor who had received a dura mater graft and was at increased risk for Creutzfeldt-Jakob Disease (CJD), were distributed.

  2. Pooled Cryoprecipitated AHF

    Reason: Pooled Cryoprecipitated AHF, collected from a donor who had received a dura mater graft and was at increased risk for Creutzfeldt-Jakob Disease (CJD), were distributed.

Recall details

Company began the recall
Company
Blood Assurance Inc
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
99415
Recall numbers
B-0171-2026 to B-0172-2026

All recalls from Blood Assurance 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.

  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA · Recall ended

  3. In FDA's weekly enforcement report

  4. Listed on Recall Canary

Summary by Recall Canary, written with AI · summary updated Oct 12, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)