Class II — Spark Biomedical Inc
| Recalling firm | Spark Biomedical Inc |
|---|---|
| Registered facility | Spark Biomedical Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output. |
| Product | Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28 |
| Quantity | 78 units |
| Distribution | US Nationwide distribution. |
| Initiated | 2025-07-02 |
| Classified | 2025-08-11 |
| Recall number | Z-2287-2025 |
| 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 — Spark Biomedical Inc (Z-2287-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97185/
Alerts for Spark Biomedical Inc
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.