FDA recall, , Moderate risk
ImpactLife Apheresis Platelets, Leukocytes Reduced
Apheresis Platelets, Leukocytes Reduced lack documentation of acceptable storage temperature and agitation.
ImpactLife began this recall on Nov 10, 2025. FDA posted it on Nov 3, 2026, the day the recall ended.
Summary by Recall Canary from the FDA notice
What happened
ImpactLife of Davenport, Iowa, voluntarily began a recall of Apheresis Platelets, Leukocytes Reduced on November 10, 2025, because the product lacked documentation of acceptable storage temperature and agitation. The FDA added the recall to its Enforcement Report and classified it on November 3, 2026. The product was distributed in New York.
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, Leukocytes Reduced
- Unit number
- W038325145969
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
- ImpactLifeDavenport, Iowa
- 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
- 100251
- Recall number
- B-0033-2027
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
ImpactLife began the recall
FDA posted the recall to its Enforcement Report, rated it Class II (moderate risk) and closed it
Added to Recall Canary