Z-0690-2017Class II

FMsealer Open Shears. Model FM3001

Name: Z-0690-2017 FMsealer Open Shears. Model FM3001
Creator: Domain Surgical, Inc.
Published: 2016-10-24
License: https://open.fda.gov/license/

Omni-Guide Holdings, Inc. / initiated 2016-10-24 / Terminated

FDA source

Domain Surgical, Inc. began a recall of FMsealer Open Shears. Model FM3001 on 2016-10-24. FDA classified it as Class II and gives the reason as "Domain Surgical, Inc. announces a voluntary field action for the FMsealer Open Shears due to fixed jaw fractures during clincal usage". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0690-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-24
Posted: 2016-12-01
Terminated: 2017-04-11
Recalling firm: Omni-Guide Holdings, Inc.
Product: FMsealer Open Shears. Model FM3001
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Domain Surgical, Inc. announces a voluntary field action for the FMsealer Open Shears due to fixed jaw fractures during clincal usage.
FDA root cause: Other
Action: Consignees were notified on 10/24/2016 via letter to return affected products to Domain Surgical, Inc.
Quantity in commerce: 70 units US; 175 units OUS
Distribution: Nationwide and other foreign consignees. No Canadian or VA/govt/military consignees.
Product codes and lots: Lots: 153411; 160321; 160531; 160991; 161311; 161442; 161871; 162091

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0690-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0690-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-07	2016-12-01

Product code GEI

K141484Class IIOpen FmsealerDomain Surgical, Inc. / cleared 2014-07-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)