Illumina, Inc. recalls
Every recall we track for Illumina, Inc. — 6 in all, from 2022–2025 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Illumina, Inc. peaked in 2022 (3); 6 since 2017.
All FDA recall records for Illumina, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 1 | 1 | 1 | 3 |
| 2023 | 0 | 0 | 1 | 1 | 2 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 1 | 0 | 1 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
Most common reasons for Illumina, Inc. recalls
What to do if you have a recalled Illumina, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Illumina, Inc. recalls
4 shown- Lower riskMedical device
Illumina, Inc. recalls Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5
Illumina recalls NextSeq 550Dx High Output Reagent Kits v2.5 due to flow cell leaks that may cause run failures, instrument clogs, or toxic exposure. Affected kits include specific model numbers and cycle counts.
IlluminaOct 28, 2025 - UnratedMedical device
Illumina, Inc. recalls MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
Illumina recalls MiSeq Dx instruments with Universal Copy Service software due to cybersecurity vulnerability. Affected units may have security risks.
IlluminaApr 5, 2023 - Lower riskMedical device
Illumina, Inc. recalls illumina Model NextSeq 550 Dx REF 20005715
Illumina recalls NextSeq 550 Dx instruments with Local Run Manager software versions 1.3.1 to 3.0 due to cybersecurity vulnerability. Affected units include specific model numbers and UDI-DI codes listed in the recall notice.
IlluminaMay 3, 2022 - Use cautionMedical device
Illumina, Inc. recalls Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
Illumina recalls NextSeq 550Dx DNA analyzers with potential short circuit after reconnection. Affected units have specific lot numbers and UDI codes. Stop using if device becomes inoperable.
IlluminaFeb 22, 2022
Illumina, Inc. recall questions
How many recalls has Illumina, Inc. had?
6 recalls from Illumina, Inc. are on record with U.S. safety agencies, from 2022–2025.
What is the most recent Illumina, Inc. recall?
Illumina, Inc. recalls Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5, dated Oct 28, 2025. Every Illumina, Inc. recall is listed on this page, newest first.
Why are Illumina, Inc. products recalled?
The most common reasons on record: cybersecurity vulnerability (2).
What should I do if I have a recalled Illumina, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Illumina, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.