Z-1815-2018Class II

Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 2.5mm ( Item Code 030451)

Name: Z-1815-2018 Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 2.5mm ( Item Code 030451)
Creator: Covidien Medtronic
Published: 2018-04-26
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2018-04-26 / Terminated / root cause: manufacturing process

FDA source

COVIDIEN MEDTRONIC began a recall of Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 2.5mm ( Item Code 030451) Product Usage: The Endo GIA universal and Endo GIA universal XL... on 2018-04-26. FDA classified it as Class II and gives the reason as "Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1815-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-26
Posted: 2018-05-16
Terminated: 2020-06-17
Recalling firm: Medtronic, Inc.
Product: Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 2.5mm ( Item Code 030451) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 2.0 mm, 2.5 mm, 3.5 mm or 4.8 mm single use loading unit. The Endo GIA universal staplers will accommodate any of the single use loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.
Product code: GDW Staple, Implantable
Reason for recall: Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On April 26, 2108, all consignees were issued were issued Urgent Medical Device Recall notices and Return Forms via Federal Express or certified mail. On May 22, 2018, all consignees received an UPDATED URGENT MEDICAL DEVICE RECALL notice. The updated notice included NEW product which has been processed under FDA Ref # 80423. The notice informs customers of the potential for use of a device with a missing sled and the actions they should take to discontinue use of the product and return all inventory of the affected lots to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. All in-control inventory and devices returned from customers will be reworked. **FOR INTERNATIONAL CUSTOMERS** Please be aware that the recalled units are packed within various convenience kits as identified on the Attachment B provided with your customer letter. Customers are also encouraged to EMAIL OR FAX THE ACKNOWLEDGEMENT FORM TO: - "Product purchased directly from Medtronic": [email protected] or fax to (800) 895-6140. - "Product purchased through distributor": [email protected] or fax it to (203) 492-7719.
Quantity in commerce: 171,271 units in total
Distribution: Worldwide and US Nationwide
Product codes and lots: Lots: N7L0071KX, N7L0527KX, N7L0792KX, N7L0914KX, N7L1014KX, N7L1159KX, N8A0154KX,N8A0553KX, N8A0850KX, N8C0830KX, N8C0847KRX, N8C0848KRX GTIN # 1 (Inner Carton) - 10884523002829 GTIN # 2 (Outer Carton)- 20884523002826

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1815-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1814-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1815-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1816-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1817-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1818-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1819-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1820-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1821-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1822-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1823-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1824-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1825-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1826-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1828-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1829-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1830-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1831-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1832-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1833-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1834-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1837-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1838-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1839-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1840-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1842-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1843-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1844-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1847-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1848-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1849-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1850-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1852-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1854-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1855-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1858-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1859-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1862-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1863-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1865-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06
Z-1866-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-07-06

Product code GDW

K111825Class IIEndo Gia(tm) Staplers, Dst Series(tm) Gia(tm) Staplers, Dst Series(tm) Ta(tm) StaplersCovidien, Formerly US Surgical A Divison of Tyco H / cleared 2011-10-25

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)