Illumina recalls

Illumina has 9 recalls on record with the FDA and USDA, the earliest in 2014 and the latest reported on 10 Dec 2025. 1 is still ongoing. 1 was reported in the last 12 months. The most frequent reason is device malfunction.

Total recalls9since 2014

Last 12 months1reported

Class I00% of total

Ongoing1latest 10 Dec 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 1 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 8 89%Class III 1 11%

Why illumina is recalled

Product types

By year

2025111%
2023222%
2022333%
2014333%

Ongoing illumina recalls

1 active

Reported	Class	Recall	Company	Reason	Where
10 Dec 2025Device	CLASS II	Reagent Kits/ containing flow cells recalled by Illumina	Illumina	Lead & Heavy Metals	Nationwide

All illumina recalls, newest first

9 total

Reported	Class	Recall	Company	Reason	Where
10 Dec 2025Device	CLASS II	Reagent Kits/ containing flow cells recalled by Illumina	Illumina	Lead & Heavy Metals	Nationwide
28 Jun 2023Device	CLASS II	NextSeq 550Dx Instrument recalled by Illumina	Illumina	Device Malfunction	Nationwide
28 Jun 2023Device	CLASS II	MiSeq Dx Instrument recalled by Illumina	Illumina	Device Malfunction	Nationwide
22 Jun 2022Device	CLASS II	illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model recalled	Illumina	Other	Nationwide
22 Jun 2022Device	CLASS II	illumina Model NextSeq 550 Dx REF recalled	Illumina	Other	Nationwide
6 Apr 2022Device	CLASS II	NextSeq 550Dx recalled by Illumina	Illumina	Other	31 states
31 Dec 2014Device	CLASS III	MiSeqDx Cystic Fibrosis Clinical Sequencing Assay recalled by Illumina	Illumina	Potency & Assay	MD, NY
31 Dec 2014Device	CLASS II	MiSeqDx Universal Kit 0, PN 15039608 The Illumina MiSeqDx recalled	Illumina	Device Malfunction	Nationwide
17 Sep 2014Device	CLASS II	Worklist Manager (IWM) recalled by Illumina	Illumina	Device Malfunction	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.