Synaptive Trackable Suction Set Standard and Malleable — Class II medical device recall Z-1955-2021
Terminated recall by Synaptive Medical Inc, reported 2021-07-07, distributed in CA, FL, IN, LA, MD, MI, NC, NV…. Due to visible burrs/metal filings affixed along the suction tube inner perimeter.
| Recall number | Z-1955-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synaptive Medical Inc, Toronto, N/A, Canada |
| Recall initiated | 2021-04-23 |
| Classified | 2021-06-25 |
| Reported by FDA | 2021-07-07 |
| Terminated | 2024-01-12 |
| Distributed | CA, FL, IN, LA, MD, MI, NC, NV, NY, OR, PA, SC, TX, VA, WI |
| Countries outside the US | AU, BE, CA, CH, GB, NL, SG, TH, VN |
| Quantity | 1,291 units |
Product
Synaptive Trackable Suction Set Standard and Malleable
Reason for recall
Due to visible burrs/metal filings affixed along the suction tube inner perimeter.
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-1955-2021. 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.