Infinity M300 telemetry monitoring device Software versions VG2 — Class II medical device recall Z-0372-2020
Ongoing recall by Draegar Medical Systems, Inc., reported 2019-11-20, distributed nationwide. The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDo
| Recall number | Z-0372-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Draegar Medical Systems, Inc., Andover, MA, United States |
| Recall initiated | 2019-10-09 |
| Classified | 2019-11-14 |
| Reported by FDA | 2019-11-20 |
| Distributed | Nationwide (US) |
| Quantity | 12,204 |
| Reason classes | software |
| Model numbers | MS18623, MS22862, MS25301, MS25755, MS26031, MS26076 |
Product
Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301
Reason for recall
The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDoS), Spoofing, and Tampering.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0372-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.