Class I — Defibtech, LLC
| Recalling firm | DEFIBTECH, LLC |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | Problem in the device's motor may cause the device to stop compressions. This may lead to a delay in therapy if the device fails to operate, and could lead to patient injury or death. |
| Product | RMU-2000 Automated Chest Compression Device |
| Quantity | 174 US, 37 OUS |
| Distribution | Domestic distribution to CT, FL, NJ, SC, TN. Foreign distribution to Japan |
| Initiated | 2024-07-12 |
| Classified | 2024-08-14 |
| Recall number | Z-2543-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Defibtech, LLC (Z-2543-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94960/
Alerts for DEFIBTECH, LLC
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.