Illumina MiSeq Dx Sequencing Instruments Recalled Due to Cybersecurity Vulnerability
Illumina is recalling approximately 1,014 MiSeq Dx sequencing instruments due to a cybersecurity vulnerability. The devices are distributed worldwide and throughout the United States.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall for cybersecurity vulnerability affecting diagnostic sequencing instruments. No reported illnesses, injuries, or deaths. Classified as high severity because cybersecurity vulnerabilities on medical devices represent a risk-of-harm scenario where patient-impacting functionality could be compromised, though no actual harm has been reported.
Plain-English summary
Illumina, Inc. is recalling approximately 1,014 MiSeq Dx sequencing instruments (model numbers DX-410-1001, 15036706, and 20014053) due to a cybersecurity vulnerability. The affected instruments contain software versions 1.3.1 through 3.0.
The recalled devices have been distributed to all 50 U.S. states and Washington D.C., as well as internationally to multiple countries including Canada, Australia, Japan, the United Kingdom, and many others.
The FDA classifies this as a Class II recall. Consumers with questions about whether they possess a recalled device should verify their instrument's model number and software version and contact Illumina, Inc. for information regarding remediation options.
The recalled product
- Product
- illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx
- Manufacturer
- Illumina, Inc.
- Hazard
- cybersecurity-vulnerability
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model Numbers: DX-410-1001
- 15036706
- 20014053
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Convenience Kits with Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- ModerateThuvera Laser Console Software Version 2.2 Recall Notice
FDA (Devices) · 2026-07-01
- HighStryker Neurovascular INZONE Detachment System battery drain
FDA (Devices) · 2026-07-01
- HighSurgify Halo surgical burr recalled for potential breakage risk
FDA (Devices) · 2026-07-01
- ModerateMedline Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01