FDA Device recall Z-0690-2017
FMsealer Open Shears
- FDA Device
- Class II
- terminated
- Published 2016-12-07
On 2016-12-07 the FDA classified a Class II recall of FMsealer Open Shears by Domain Surgical, citing domain Surgical, Inc. announces a voluntary field action for the FMsealer Open Shears due to fixed jaw fractures during clincal usage.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0690-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-24 |
| Published | 2016-12-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Domain Surgical |
| Distribution | US |
Product
FMsealer Open Shears. Model FM3001
Reason
Domain Surgical, Inc. announces a voluntary field action for the FMsealer Open Shears due to fixed jaw fractures during clincal usage.
Identifiers
| code_info | Lots: 153411; 160321; 160531; 160991; 161311; 161442; 161871; 162091 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0690-2017%22
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