The FDA has posted 14 enforcement recalls of blood collection serum separators systems vials tubes devices since 2025, none of them Class I (most serious). Most recent report: Jan 21, 2026.
Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery.…
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Some of the Vacuette¿ CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and require the patient to return to the lab for recollection or repeat te…
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Tubes, Vials, Systems, Serum Separators, Blood Collection”). Informational only — verify against the FDA before acting.