Class II — Coapt LLC
| Recalling firm | Coapt, LLC |
|---|---|
| Registered facility | Coapt LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged. |
| Product | Coapt ControlSeal Electrode, cutaneous EMG Electrode |
| Quantity | 109 devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Canada, and Sweden. |
| Initiated | 2023-10-02 |
| Classified | 2023-10-31 |
| Recall number | Z-0204-2024 |
| 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 II recall — Coapt LLC (Z-0204-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93138/
Alerts for Coapt, 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.