Coapt Dome Electrode — Class II medical device recall Z-0203-2024
Ongoing recall by Coapt LLC, reported 2023-11-08, distributed nationwide. Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatur
| Recall number | Z-0203-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Coapt LLC, Chicago, IL, United States |
| Recall initiated | 2023-10-02 |
| Classified | 2023-10-31 |
| Reported by FDA | 2023-11-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | SE |
| Quantity | 247 devices |
Product
Coapt Dome Electrode, Gen2 system, cutaneous electrode
Reason for recall
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.
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-0203-2024. 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.