Drug recall

Apheresis Red Blood Cells, Leukocytes Reduced

FDA recall event 99092 · Class II · OneBlood, Inc.

Key facts

Event ID 99092
Recall numbers B-0100-2026
Recalling firm OneBlood, Inc.
Product type Biologics
Products Apheresis Red Blood Cells, Leukocytes Reduced
Classification Class II
Status Terminated
Voluntary or mandated Voluntary: Firm Initiated
Reason for recall Apheresis Red Blood Cells, Leukocytes Reduced, which were labeled as leukocytes reduced but were not tested to verify white blood cell count, were distributed.
Initiation date Jul 21, 2025
Report date Jul 8, 2026
Termination date Jun 26, 2026
City Orlando
State FL
Country United States
FEI number 1072425

At a glance

  • 1–9 Products in this recall
  • 10–99 FDA inspections of this firm (FEI)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date:

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