FDA recall, , Moderate risk
American Red Cross Apheresis Platelets
Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced lack documentation of return to acceptable storage temperature.
American Red Cross Biomedical Services Northern New England Region began this recall on Oct 29, 2025. FDA posted it on Nov 3, 2026, the day the recall ended.
Summary by Recall Canary from the FDA notice
What happened
American Red Cross Biomedical Services Northern New England Region, based in Burlington, Vermont, voluntarily initiated a recall of Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced on October 29, 2025, because the product lacked documentation of return to acceptable storage temperature. The FDA added the recall to its Enforcement Report on November 3, 2026, and classified it that same day. Customers were notified by telephone. The recall affects product distributed in Vermont.
What to do
Biologics such as blood, tissue and vaccines are usually given by hospitals and clinics. If you had a transfusion, transplant, infusion or vaccine, ask the place that treated you whether this product was used. If they contact you, follow their advice.
What was recalled
Hospitals, clinics and blood banks match these details against their records.
Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced
- Unit number
- W18342583978000C
Recall details
- Posted by FDA
- Recall began
- Status
- Ended Nov 3, 2026
- Weekly archive
- Listed the week of Nov 2, 2026
- Distributed to
- Recalled by
- American Red Cross Biomedical Services Northern New England RegionBurlington, Vermont
- Risk
Moderate risk
Its use may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 100022
- Recall number
- B-0004-2027
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Telephone
All recalls from American Red Cross Biomedical Services Northern New England Region
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
American Red Cross Biomedical Services Northern New England Region began the recall
FDA posted the recall to its Enforcement Report, rated it Class II (moderate risk) and closed it
Added to Recall Canary
