Class II — Synaptive Medical Inc
| Recalling firm | Synaptive Medical Inc |
|---|---|
| Registered facility | Synaptive Medical Inc (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Due to visible burrs/metal filings affixed along the suction tube inner perimeter. |
| Product | Synaptive Trackable Suction Set Standard and Malleable |
| Quantity | 1291 units |
| Distribution | Domestic Distribution: IN, SC, MD, OR, TX ,LA, MI, NY, NV, FL, VA, CA,WI, PA and NC. International Distribution: Australia, Canada, Belgium, Netherlands, Singapore, Switzerland, Thailand, UK, Vietnam |
| Initiated | 2021-04-23 |
| Classified | 2021-06-25 |
| Terminated | 2024-01-12 |
| Recall number | Z-1955-2021 |
| 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 — Synaptive Medical Inc (Z-1955-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87937/
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