Unrated Medical device recall · FDA · Published October 9, 2019

Draegar Infinity M300 Software Versions VG2.3.1 and Lower Cybersecurity Risk

Draegar recalls Infinity M300 telemetry monitoring devices with software versions VG2.3.1 and lower due to cybersecurity vulnerabilities including DDoS, spoofing, and tampering risks.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0372-2020Medical device Draegar ›

Recall notice

The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDoS), Spoofing, and Tampering.

Take action

Contact the company

Recalling firmDraegar Medical Systems, Inc.6 Tech Dr · Andover, MA 01810-2434

✎ GovInfoNow plain-language explainer

Draegar is recalling Infinity M300 telemetry monitoring devices with software versions VG2.3.1 and lower because they have cybersecurity vulnerabilities that could allow unauthorized access, data tampering, or denial of service attacks. This affects medical devices used in healthcare settings where security is critical. Read more at govinfonow.com/recall/66860-draegar-infinity-m300-software-versions-vg2-3-1-and-lower.

Source Summary by GovInfoNow · govinfonow.com/recall/66860-draegar-infinity-m300-software-versions-vg2-3-1-and-lower · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0372-2020

Cite this page

“Draegar Infinity M300 Software Versions VG2.3.1 and Lower Cybersecurity Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66860-draegar-infinity-m300-software-versions-vg2-3-1-and-lower. Based on FDA recall #Z-0372-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0372-2020%22&limit=1).

The FDA announced on 2019-10-09 that Draegar Medical Systems, Inc. is recalling Infinity M300 telemetry monitoring devices due to potential cybersecurity vulnerabilities. The agency issued recall number Z-0372-2020 for the Class II voluntary recall.

How to tell if you have it

Brand: Draegar
Product: Infinity M300 telemetry monitoring device
Software versions: VG2.3.1 and lower
Model Numbers: MS25755, MS26076, MS26031, MS18623, MS22862, MS25301
Quantity: 12,204 units

The hazard

According to the FDA, the devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDoS), Spoofing, and Tampering.

Context

GovInfoNow's records show Draegar Medical Systems, Inc. has had 8 other recalls on record since 2017-06-06. Other recent recalls of similar products include GE Medical Systems Centricity Universal Viewer Software Cybersecurity Recall (2026-01-30), Edan Vital Signs Monitor M3A: Cybersecurity Risk - Recall (2025-10-24), and GE Healthcare Patient Monitor Software Vulnerability: Unauthorized Access Risk (2026-07-10).

How to tell if you have this one

Check if your Infinity M300 device has software version VG2.3.1 or lower, or model numbers MS25755, MS26076, MS26031, MS18623, or MS22862. The devices were sold to healthcare facilities and may be used in medical settings.

Brand
Draegar
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Identify your device's software version by checking the device settings or documentation.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 42 days after the firm started it.

Oct 9, 2019Firm started the recall
Nov 14, 2019FDA classified it Class II
Nov 20, 2019Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Draegar recalls

Link to this recall

<a href="https://govinfonow.com/recall/66860-draegar-infinity-m300-software-versions-vg2-3-1-and-lower">Draegar Infinity M300 Software Versions VG2.3.1 and Lower Cybersecurity Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0372-2020 (October 9, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0372-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.