Z-1836-2019Class II

Signia Tri-Staple 2.0 Curved Tip 60Mm Medium/ Thic , Sig60ctamt

Name: Z-1836-2019 Signia Tri-Staple 2.0 Curved Tip 60Mm Medium/ Thic , Sig60ctamt
Creator: Covidien LLC
Published: 2019-05-17
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2019-05-17 / Open, Classified / root cause: manufacturing process

FDA source

Covidien LLC began a recall of SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT on 2019-05-17. FDA classified it as Class II and gives the reason as "The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which...". 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-1836-2019
Classification: Class II
Status: Open, Classified
Initiated: 2019-05-17
Posted: 2019-06-16
Recalling firm: Medtronic, Inc.
Product: Signia Tri-Staple 2.0 Curved Tip 60Mm Medium/ Thic , Sig60ctamt
Product code: GDW Staple, Implantable
Reason for recall: The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: All consignees were notified by letter delivered via Federal Express and/or certified mail beginning May 17, 2019. The letter informs customers of the recall of specific item codes and production lots of Covidien Endo GIA Articulating Reloads with Tri-Staple Technology due to the potential for a device to be missing one of two pin components that maintain alignment of the device jaws. Through this notification customers are instructed to take the following actions: " Immediately quarantine and discontinue use of the affected item codes and lots. " Return affected product. " Forward the information to anyone who they have distributed affected Covidien Endo GIA" Articulating Reloads with Tri-Staple Technology. " Complete the Recalled Product Return Form. If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.
Quantity in commerce: 3,113,280
Distribution: Nationwide domestic distribution, worldwide foreign distribution.
Product codes and lots: N6E0295UX N6H0576UX N6J1092UX N6K0230UX N6K0938UX N6L0422URX N6L0777UX N6M0607UX N7A0415UX N7C0112X N7D1013X N7E1089X N7F0275X N7F1126X N7G0444X N7H0047X N7H1067X N7J0175X N7L0825X N8A0249X N8A0655X N8B0455X N8B0945X N8C0757X N8C1213X N8D0593X N8D0907X N8E0015X N8G0648X N8J0764X N8K0823KY N8K0840Y N8L0166Y N8L0436Y N8M0845Y N9A0204Y N9B0455Y

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1836-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1825-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1826-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1827-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1828-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1829-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1830-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1831-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1832-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1833-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1834-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1835-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1836-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-06-26	2019-06-15

Product code GDW

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)