FDA Device recall Z-1955-2021
Synaptive Trackable Suction Set Standard and Malleable
- FDA Device
- Class II
- terminated
- Published 2021-07-07
On 2021-07-07 the FDA classified a Class II recall of Synaptive Trackable Suction Set Standard and Malleable by Synaptive Medical, citing due to visible burrs/metal filings affixed along the suction tube inner perimeter.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1955-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-23 |
| Published | 2021-07-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Synaptive Medical |
| Distribution | CA, FL, IN, LA, MD, MI, NC, NV, NY, OR, PA, SC, TX, VA, WI |
Product
Synaptive Trackable Suction Set Standard and Malleable
Reason
Due to visible burrs/metal filings affixed along the suction tube inner perimeter.
Identifiers
| code_info | Set and components codes: SYN-0657, SYN-0783 Consumables 3 Packs SYN-0663, SYN-0664, SYN-0665, SYN-0666, SYN-0667,…Set and components codes: SYN-0657, SYN-0783 Consumables 3 Packs SYN-0663, SYN-0664, SYN-0665, SYN-0666, SYN-0667, SYN-0668, SYN-0759, SYN-0760, SYN-0761, SYN-0762, SYN-0763, SYN-0764, SYN-0765 and SYN-0766. Consumables Singles SYN- 0651, SYN-0652, SYN-0653, SYN-0654, SYN-0655, SYN-0656, SYN-0671,SYN-0672, SYN-0673, SYN-0674, SYN-0675, SYN-0676, SYN-0677 and SYN-0778. All lots and all serial numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1955-2021%22
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