Z-1832-2019Class II

Signia Tri-Staple 2.0 30Mm Medium/ Thick Reload , Sig30amt

Name: Z-1832-2019 Signia Tri-Staple 2.0 30Mm Medium/ Thick Reload , Sig30amt
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 30MM MEDIUM/ THICK RELOAD , SIG30AMT 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-1832-2019
Classification: Class II
Status: Open, Classified
Initiated: 2019-05-17
Posted: 2019-06-16
Recalling firm: Medtronic, Inc.
Product: Signia Tri-Staple 2.0 30Mm Medium/ Thick Reload , Sig30amt
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: N6E0033UX N6H0768UX N6H0772UX N6K0521UX N6K0522UX N6K0667UX N6K0668UX N6L0687UX N6M0399UX N7A0018UX N7A0213UX N7A0401UX N7A0837UX N7B0787UX N7C0238X N7C0470X N7E0496X N7E1088X N7F0670X N7H0962X N7J0370X N8A0188X N8B0057X N8B0483X N8B0940X N8D0365X N8D0649X N8E0092X N8E0213X N8E0516X N8E1178X N8F0483X N8F0819X N8F0974X N8J0440X N8L0589Y N8M0529Y N9A0050Y N9A0427Y

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1832-2019
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)