Device recall: Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm- 2.0mm ( Item Code 030450) Product Usage: The Endo GIA u
FDA enforcement event 79974 is a device recall by an individual recalling firm (name withheld) of NORTH HAVEN, CT, initiated 26 Apr 2018 and classified Class II, with 40 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 17 Jun 2020. Initiation: voluntary: firm initiated.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Individual recalling firm (name withheld), NORTH HAVEN, CT. FDA names an individual as the recalling firm; this site does not publish people's names.
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."
Distribution
"Worldwide and US Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1814-2018 | Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm- 2.0mm ( Item Code 030450) 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… | 171,271 units in total | Class II | Terminated | 23 May 2018 |
| Z-1815-2018 | 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… | 171,271 units in total | Class II | Terminated | 23 May 2018 |
| Z-1816-2018 | Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 3.5mm ( Item Code 030452) 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… | 171,271 units in total | Class II | Terminated | 23 May 2018 |
| Z-1817-2018 | Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm - 2.5mm( Item Code 030454) 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… | 171,271 units in total | Class II | Terminated | 23 May 2018 |
| Z-1818-2018 | Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm- 3.5mm( Item Code 030455) 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… | 171,271 units in total | Class II | Terminated | 23 May 2018 |
| Z-1819-2018 | Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm -2.5mm ( Item Code 030457) 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… | 171,271 units in total | Class II | Terminated | 23 May 2018 |
| Z-1820-2018 | Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm - 3.5mm ( Item Code 030458) 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… | 171,271 units in total | Class II | Terminated | 23 May 2018 |
| Z-1821-2018 | Endo GIA" 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology( Item Code EGIA30CTAV) 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… | 171,271 units in total | Class II | Terminated | 23 May 2018 |
| Z-1822-2018 | Endo GIA" 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology( Item Code EGIA30AV) 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… | 171,271 units in total | Class II | Terminated | 23 May 2018 |
| Z-1823-2018 | Endo GIA" 45mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology( Item Code EGIA45CTAV) 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… | 171,271 units in total | Class II | Terminated | 23 May 2018 |
| Z-1824-2018 | Covidien" Best Practices" Procedure Kits containing Auto Suture" Endo GIA" Devices 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… | 171,271 units in total | Class II | Terminated | 23 May 2018 |
| Z-1825-2018 | BOX KIT1095V KIT OBESITAS (Item Code KIT1095V) 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… | 171,271 units in total | Class II | Terminated | 23 May 2018 |
| Z-1826-2018 | (1) BOX 01KBAR006116V PROC BYPASS 01KBAR0061(Item Code 01KBAR006116V PROC BYPAS) (2) BOX 1073076GASB0 BBR STVEIT GASTRIC B (Item Code BOX1073076GASB0) (3) BOX BOX1073076GASB0 BBR STVEIT GASTRIC B (Item Code BOX1073076GASB0 BBR STVEIT GASTRIC B) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers… | 171,271 units in total | Class II | Terminated | 23 May 2018 |
| Z-1828-2018 | BOX1073076GASB1 BBR GASTRIC BYPASS S(Item Code BOX1073076GASB1 BBR GASTRIC BYPASS S) 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… | 171,271 units in total | Class II | Terminated | 23 May 2018 |
| Z-1829-2018 | (1) BOX BOX1073180 APPE1 APPENDIX KIT ZAMS (Item Code BOX1073180) (2)BOX BOX1073180APPE1 APPENDIX KIT ZAMS (Item Code BOX1073180APPE1 APPENDIX KIT ZAMS) 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… | 171,271 units in total | Class II | Terminated | 23 May 2018 |
| Z-1830-2018 | (1)BOX HEMIGX1 ZESTAW DO HEMICOLECTOMII (Item Number HEMIGX1 ZESTAW DO HEMICOLECTOMII) (2) BOX LAPPH ZASTAW DO PRAWEJ HEMIKOLEKTOMI (item number: LAPPH ZASTAW DO PRAWEJ HEMIKOLEKTOMI Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and… | 171,271 units in total | Class II | Terminated | 23 May 2018 |
| Z-1831-2018 | KIT00486R OBESIDAD D. WORWARLD 2 X1 (Item Number KIT00486R) 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… | 171,271 units in total | Class II | Terminated | 23 May 2018 |
| Z-1832-2018 | BOX KIT00713 KIT BY PASS 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… | 171,271 units in total | Class II | Terminated | 23 May 2018 |
| Z-1833-2018 | BOX KIT00714 KIT SLEEVE 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… | 171,271 units in total | Class II | Terminated | 23 May 2018 |
| Z-1834-2018 | BOX KIT1171C KIT LAP CYSTECTOMY 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… | 171,271 units in total | Class II | Terminated | 23 May 2018 |
| Z-1837-2018 | KIT-DE-0080 BYPASS KIT LOHNE X1( Item KIT-DE-0080) 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… | 171,271 units in total | Class II | Terminated | 23 May 2018 |
| Z-1838-2018 | (1)KIT4184 APEN LOBECTOMY KIT X0 Item Number: KIT4184 APEN LOBECTOMY KIT XO (2) BOX VATSLOB11 ZESTAW DO VATS LOBECTOMII (Item Number: VATSLOB11, VATSLOB11 ZESTAW DO VATS LOBECTOMII Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and… | 171,271 units in total | Class II | Terminated | 23 May 2018 |
| Z-1839-2018 | BOX KITDE0108 BYPASS KIT LUEBECK ( KITDE0108) 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… | 171,271 units in total | Class II | Terminated | 23 May 2018 |
| Z-1840-2018 | (1) BOX KITDE0143 BYPASS BOX (Item Number: KITDE0143, KITDE0143 BYPASS BOX) (2) BOX KITDE0154 BYPASS KH NORDWEST (Item Number: KITDE0154, KITDE0154 BYPASS KH NORDWEST Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously… | 171,271 units in total | Class II | Terminated | 23 May 2018 |
| Z-1842-2018 | (1)BOX KITDE0183 APPENDIX LIPPE DETMOLD (KITDE0183) (2) KIT-DE-0083 APPENEKTOMIE KIT NAUENX1 (Item Number: KIT-DE-0083,KIT-DE-0083 APPENEKTOMIE KIT NAUENX1 Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the… | 171,271 units in total | Class II | Terminated | 23 May 2018 |
| Z-1843-2018 | (1)LAPBARLECZNA ZESTAW BARIATRYCZNY LECZNA (2) KITBAR021- BARIATRIC KIT X1 Item Code:KITBAR021- BARIATRIC KIT X0 (3)BOX SGGLOGX1 ZESTAW DO BARIATRII Item Code: SGGLOGX1 ZESTAW DO BARIATRII (4)BOX SGGLOGX1 ZESTAW DO BARIATRII Item Coder:SGGLOGX1 ZESTAW DO BARIATRII (5)BOX SGSWP1 ZESTAW DO RESEKCJI REKAWOWEJ Item… | 169,775 units in total | Class II | Terminated | 23 May 2018 |
| Z-1844-2018 | BOX LAPIMBGP1 ZESTAW DO MGBP (LAPIMBGP1) 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… | 169,775 units in total | Class II | Terminated | 23 May 2018 |
| Z-1847-2018 | (1) BOX LAPZD ZESTAW DO SG (2) BOX LAPISG1 ZESTAW DO SG (3) BOX LAPISGW ZESTAW DO SG 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… | 169,775 units in total | Class II | Terminated | 23 May 2018 |
| Z-1848-2018 | BOX MGBGLOGX1 ZESTAW MINI GASTRIC BYPASS 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… | 169,775 units in total | Class II | Terminated | 23 May 2018 |
| Z-1849-2018 | (1)BOX PST01199 BARIATRIC TRISTAPLE (Item Number: PST01199) (2) BOX PST03403 ALTERNATIVE APPENDIX KIT (Item Number: PST03403) (3) BOX PST03533 KIT APP STAPLER (Item Number: PST03403) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and… | 169,775 units in total | Class II | Terminated | 23 May 2018 |
| Z-1850-2018 | MGBX ZESTAW GB LS X1 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… | 169,775 units in total | Class II | Terminated | 23 May 2018 |
| Z-1852-2018 | BOX PST03533 KIT APP STAPLER 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… | 169,775 units in total | Class II | Terminated | 23 May 2018 |
| Z-1854-2018 | BOX PST03699 KIT APP MED ALTERNATIV STAP 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… | 169,775 units in total | Class II | Terminated | 23 May 2018 |
| Z-1855-2018 | (1)BOX PST04089 SLEEVE AIWA CLINIC Item Number:PST04089 SLEEVE AIWA CLINIC (2)BOX PST04090 BYPASS AIWA CLINIC Item Number: PST04090 BYPASS AIWA CLINIC 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… | 169,775 units in total | Class II | Terminated | 23 May 2018 |
| Z-1858-2018 | SLEEVEGK1 ZESTAW DO ZABIEGOW SLEEVEX1 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… | 169,775 units in total | Class II | Terminated | 23 May 2018 |
| Z-1859-2018 | (1)BOX SLEEVEGK3 (2) BOX SLEEVEGK4 SLEEVE GASTRECTOMY (3)BOX SLEEVEJAWI SLEEVE GASTRECTOMY BOX (4) SSLEEVE ZEST DO SLEEVE GASTREKTOMIIX1 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,… | 169,775 units in total | Class II | Terminated | 23 May 2018 |
| Z-1862-2018 | BOX TGGLOGOWX1 DO TOTAL GASTRECTOMIII 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… | 169,775 units in total | Class II | Terminated | 23 May 2018 |
| Z-1863-2018 | BOX VATS1SCDX DO ZABIEGOW VATS 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… | 169,775 units in total | Class II | Terminated | 23 May 2018 |
| Z-1865-2018 | BOX VMIN ZESTAW DO VATS PODSTAWOWY 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,… | 169,775 units in total | Class II | Terminated | 23 May 2018 |
| Z-1866-2018 | BOX VWR ZESTAW DO VATS KLIN 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… | 169,775 units in total | Class II | Terminated | 23 May 2018 |
Context
92%of 2018 device events are Class II1,074 events that year
40product records in this event
1event on this register for the firm
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide and US Nationwide"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 17 Jun 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.