FMsealer Open Shears — Class II medical device recall Z-0690-2017
Terminated recall by Domain Surgical, Inc., reported 2016-12-07, distributed nationwide. Domain Surgical, Inc. announces a voluntary field action for the FMsealer Open Shears due to fixed jaw fractur
| Recall number | Z-0690-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Domain Surgical, Inc., Salt Lake City, UT, United States |
| Recall initiated | 2016-10-24 |
| Classified | 2016-12-01 |
| Reported by FDA | 2016-12-07 |
| Terminated | 2017-04-11 |
| Distributed | Nationwide (US) |
| Reason classes | device malfunction |
| Lot numbers | 153411, 160321, 160531, 160991, 161311, 161442, 161871, 162091 |
| Model numbers | FM3001 |
Product
FMsealer Open Shears. Model FM3001
Reason for recall
Domain Surgical, Inc. announces a voluntary field action for the FMsealer Open Shears due to fixed jaw fractures during clincal usage.
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-0690-2017. 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.