Illumina, Inc.
Complete recall history across all FDA and CPSC categories — 6 total recalls
Illumina, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (6)
FDA medical device enforcement actions by Illumina, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Oct 28, 2025 | Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: ... | An instrument intended for sequencing DNA libraries with in vitro diagnostic ... | Class II |
| Apr 5, 2023 | NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Servic... | Cybersecurity vulnerability concerning the software used for sequencing instr... | Class II |
| Apr 5, 2023 | MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS... | Cybersecurity vulnerability concerning the software used for sequencing instr... | Class II |
| May 3, 2022 | illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSe... | cybersecurity vulnerability | Class II |
| May 3, 2022 | illumina Model NextSeq 550 Dx REF 20005715 | cybersecurity vulnerability | Class II |
| Feb 22, 2022 | Illumina NextSeq 550Dx, REF: 20005715, CE, IVD | There is a potential that the DNA sequence analyzer may short circuit shortly... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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