Z-0486-2026Class II

Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D...

Name: Z-0486-2026 Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D...
Creator: Covidien, LP
Published: 2025-09-25
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2025-09-25 / Open, Classified / root cause: manufacturing process

FDA source

Covidien, LP began a recall of Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4 on 2025-09-25. FDA classified it as Class II and gives the reason as "A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0486-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-25
Posted: 2025-11-07
Recalling firm: Medtronic, Inc.
Product: Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;
Product code: GDW Staple, Implantable
Reason for recall: A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On September 25, 2025 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Customer actions: Identify and quarantine all unused impacted product listed. Return all quarantined devices to Medtronic. If purchased from a distributor, contact your distributor directly to arrange for the return of the devices back to your distributor. Please complete and return the enclosed Customer Confirmation Form. Pass on this notice to all those who need to be aware within your organization or to any organization where the listed affected lots may have been transferred or distributed.
Quantity in commerce: 2 units (OUS only)
Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Chile, Estonia, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Kuwait, Malaysia, Netherlands, Poland, Portugal, Romania, Saudi Arabia, Slovakia, Spain, United Kingdom.
Product codes and lots: CFN: BOX06170V4; UDI-DI: 00763000988975; Lot numbers: 0231961695;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0486-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0485-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-19	2025-11-07
Z-0486-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-19	2025-11-07

Product code GDW

K191070Class IISignia Small Diameter ReloadsCovidien / cleared 2019-09-04

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)