FDA Medical Device Recalls (openFDA)
Domain Surgical, Inc.: FMsealer Open Shears. Model FM3001
- Recall number
- Z-0690-2017
- Recalling firm
- Domain Surgical, Inc.
- Product
- FMsealer Open Shears. Model FM3001
- Status
- Terminated
- Initiated
- 2016-10-24
- Posted
- 2016-12-01
- Terminated
- 2017-04-11
- Reason
- Domain Surgical, Inc. announces a voluntary field action for the FMsealer Open Shears due to fixed jaw fractures during clincal usage.
- Root cause
- Other
- Action
- Consignees were notified on 10/24/2016 via letter to return affected products to Domain Surgical, Inc.
- Quantity
- 70 units US; 175 units OUS
- Distribution
- Nationwide and other foreign consignees. No Canadian or VA/govt/military consignees.
- Lot, serial or model codes
- Lots: 153411; 160321; 160531; 160991; 161311; 161442; 161871; 162091
- 510(k) numbers
- ["K141484"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 3005350457
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28