Illumina, Inc. Recalls

Overview of recall records associated with Illumina, Inc., including dates, categories and classifications where available.

4recall records

Dec 10, 2025latest record date

Jun 22, 2022earliest record date

Recall history in this database

Classification mix: Class II: 4.

Medical DeviceDec 10, 2025

Illumina Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument recall — FDA Z-0884-2026

An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow cell gaskets that have a quality issue,…

Class IIFDA: OngoingIllumina, Inc.

Medical DeviceJun 28, 2023

Illumina MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) recall — FDA Z-1977-2023

Cybersecurity vulnerability concerning the software used for sequencing instruments.

Class IIFDA: CompletedIllumina, Inc.

Medical DeviceJun 28, 2023

Illumina NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service recall — FDA Z-1976-2023

Cybersecurity vulnerability concerning the software used for sequencing instruments.

Class IIFDA: CompletedIllumina, Inc.

Medical DeviceJun 22, 2022

illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF recall — FDA Z-1259-2022

cybersecurity vulnerability

Class IIFDA: CompletedIllumina, Inc.

Understanding this recall history

This page summarizes recall records in which the official source identifies Illumina, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.

Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.