COVIDIEN MEDTRONIC: 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.

Agency Publication Date: May 16, 2018

Affected Products

Product: 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 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 loadin

Lots: N7L0306KX, N7M0221KX, N8B0724KX, N8C0958KX, N8C1303KRX GTIN # 1 (Inner Carton) -GTIN #1 10884523002812 GTIN # 2 (Outer Carton)- GTIN # 2 20884523002819

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 loadi

Lots: N7L0071KX, N7L0527KX, N7L0792KX, N7L0914KX, N7L1014KX, N7L1159KX, N8A0154KX,N8A0553KX, N8A0850KX, N8C0830KX, N8C0847KRX, N8C0848KRX GTIN # 1 (Inner Carton) - 10884523002829 GTIN # 2 (Outer Carton)- 20884523002826

Product: 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 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 loadi

Lots: N7L0191KX, N7M0944KX, N8B0234KX,N8C0147KX GTIN # 1 (Inner Carton) - 10884523002836 GTIN # 2 (Outer Carton)- 20884523002833

Product: 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 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 load

Lots: N7K1146KX, N7L0355KX, N7L1119KX, N7M0088KX, N7M0343KX, N7M0477KRX, N7M0509KX, N7M0520KX, N7M0521KX, N8A0312KRX, N8A0360KX, N8A0433KX, N8A0434KX, N8A0435KX, N8B0487KX, N8C0026KX, N8C0119KX, N8C0630KX GTIN # 1 (Inner Carton) - 10884523002850 GTIN # 2 (Outer Carton)- 20884523002857

Product: 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 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

Lots: N7F0576KX, N7L0032KX, N7L0239KX, N7L0519KX, N7M0104KX, N7M0383KX, N7M0584KX, N7M0696KX, N8A0036KX, N8A0324KX, N8A0477KRX, N8A0551KX, N8C0357KX GTIN # 1 (Inner Carton) - 10884523002867 GTIN # 2 (Outer Carton)- 20884523002864

Product: 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 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 loadin

Lots: N7D0492KRX, N7F0518KX, N7F0651KX, N7L0270KX, N7L0699KX, N7L0732KX, N7L1043KX, N8A0213KX, N8B0002KX, N8C0429KX GTIN # 1 (Inner Carton) - 10884523002881 GTIN # 2 (Outer Carton)- 20884523002888

Product: 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 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 loadi

Lots: N7L0911KX, N7M0067KX, N7F0631KX, N7L0465KX, N7L0117KX, N7L0768KX, N7M0314KX,N7M0314KX,N7L1075KX, N7M0646KX, N7M0740KX, N7M0972KX, N8A0172KX, N8A0539KX, N8A0679KX, N8A0910KX, N8A0961KX, N8B0054KX, N8B0099KX, N8C0008KX, N8C0205KX, N8C0532KX, N8C0571KX, N8C0758KX, N8C0795KX, N8C1284KRX GTIN # 1 (Inner Carton) - 10884523002898 GTIN # 2 (Outer Carton)- 20884523002895

Product: 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 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 th

Lot: N7G0756KX & N7L0819KX

Lot Numbers:

N7G0756KX

Product: 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 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

Lot: N7G0757KX GTIN # 1 (Inner Carton) - 10884521186095 GTIN # 2 (Outer Carton)- 20884521186092

Lot Numbers:

N7G0757KX

Product: 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 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 th

Lot: N7G0796KX & N7L0818KX

Lot Numbers:

N7G0796KX

Product: 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 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

00Z2403, 00Z2293, 00Z2200, 00Z2745, 00Z2650, 00Z2648, 00Z2429, 00Z2287, 00Z2117, 00Z2482, 00Z2582, 00Z2096, 00Z2273, 00Z2544, 00Z2577A, 00Z2366, 00Z2689, 00Z2408, 00Z2707, SIGEVAL4, 00Z2516, 00Z2450, 00Z2651, 00Z2706, 00Z2117, IDRIVEXLAMTAXT, 00Z2610, 00Z2419, 00Z2451, IDRIVEXLAMT, 00Z2286, 00Z2556, 00Z2452, 00Z2201 & ADAPTRE12

Product: 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 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, 4

Lot 0214062622

Lot Numbers:

0214062622

Product: (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 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 de

(1)Lot Number :0214710711 (2) Lot Number: 0214043771,0214232317,0214375093 (3) Lot Number: 0215113531,0215132607

Lot Numbers:

Number

Product: 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 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 si

Lot 0215227169

Lot Numbers:

0215227169

Product: (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 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 uni

(1) Lot Number: 0214050554 (2) Lot Numbers: 0214907029,0214991119,0215130754,0215158268

Lot Numbers:

Number

Numbers

Product: (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 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 s

Lot Numbers: (1) 0214909888,0214916144 (2) 0215015272, 0215298205

Lot Numbers:

Numbers

Product: 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 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 a

Lot Numbers: 0213984473,0213583578,0213596057,0214068986, 0213589227

Lot Numbers:

Numbers

Product: 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 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

Lots 0214364763, 0214456590, 0214435328, 0214983139, 0215042012, 0215234651, 0215288296

Product: 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 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.

Lots 0214915642, 0214983138, 0215159225, 0215234652

Product: 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 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 m

Lots 0214090852, 0214522213, 0215009132, 0215153445

Product: 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 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

Lots 0214049646, 0214370002, 0214470664, 0215208426

Product: (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 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

(1)Lot Number: 0214962218 (2) Lot Numbers: 02148663335, 0214993030, 0215178525

Lot Numbers:

Number

Numbers

Product: 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 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,

Lot: 0214894171

Lot Numbers:

0214894171

Product: (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 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 u

Lot Numbers: (1) 0214463634, 0215280952 (2) 0214013887, 0214144177,0214260194,0214470767,0214956044 0214620382, 0214744957, 0215079103, 0215151206

Lot Numbers:

Numbers

Product: (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 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 G

Lot Numbers (1) 0214014173, 0214573291, 0214621781, 0214909631, 0215068744,0215068743, 0215108744, 0215108743, 0215276369 (2)0214798114,0214618312, 0214795633,0215002022,0215010930, 0215010931,0215010932,0215132611,0215132612,0215132613, 0215264173

Lot Numbers:

Numbers

Product: (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 Code:SGSWP1 ZESTAW DO RESEKCJI REKAWOWEJ Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows

Lot Numbers: (1) 0214049704, 0214529057, 0215176564 (2) 0215065486 (3) 0215017846 (4) 0215191012 (5) 0215218687

Lot Numbers:

Numbers

Product: 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 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 m

Lots: 0214930629, 0214993038, 0215068848, 0215124286, 0215124285, 0214793818, 0215130759,0215243237

Product: (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 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

(1) Lot: 0215082707, 0215176563 (2) Lot numbers: 0214993037,0214793817,0214930628 0214930630, 0215068849, 0215124284, 0215243236, 0214925902 0214925904, 0214925903, (3) Lot Number: 0215120700

Lot Numbers:

0215082707

numbers

Number

Product: 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 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

Lot: 0215124172, 0215253056

Lot Numbers:

0215124172

Product: (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 simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of th

Lot Numbers: (1) 0214109631, 0214909770 (2) 0214975597 (3) 0214860061

Lot Numbers:

Numbers

Product: 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 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.

Lot: 0215017845, 0215002541, 0215104507

Lot Numbers:

0215017845

Product: 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 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 l

Lots: 0214860061, 0215036240, 0215036239, 0215036238, 0215018854, 0215018855, 0215102248, 0215102247, 0215068747, 0215068748, 0215050427, 0215102246, 0215050429, 0215050428, 0215068746, 0215117409, 0215117411, 0215117410, 0215125963, 0215125962, 0215125964, 0215275313, 0215275315, 0215275314, 0215282505, 0215282506

Product: 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 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

Lots: 0215050309, 0215108007, 0215050310, 0215050308, 0215050311, 0215050312, 0215050313, 0215037144,0215037143, 0215108008

Product: (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 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

Lot Numbers: (1) 0215237526, 0214991351, 0214991350, 0215157998, 0215157997 (2) 0215237527, 0215282382, 0214991349, 0214991348, 0214991347

Lot Numbers:

Numbers

Product: 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 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 an

Lot: 0215244887

Lot Numbers:

0215244887

Product: (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, 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 En

Lot Numbers: (1) 0215050387, 0215193250 (2) 0214933111 (3) 0214030210, 0215041719, 0215161529, 0215272924 (4) 0214985253, 0215104506 , 0215298203

Lot Numbers:

Numbers

Product: 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 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 an

Lot 0214726876

Lot Numbers:

0214726876

Product: 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 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

Lots: 0214874566, 0215001737, 0215151361

Product: 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, 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 6

Lots: 0215122341, 0215226207

Product: 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 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 li

Lots:0215122344

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79974

Status: Resolved

Manufacturer: COVIDIEN MEDTRONIC

Manufactured In: United States

Units Affected: 40 products (171,271 units in total; 171,271 units in total; 171,271 units in total; 171,271 units in total; 171,271 units in total; 171,271 units in total; 171,271 units in total; 171,271 units in total; 171,271 units in total; 171,271 units in total; 171,271 units in total; 171,271 units in total; 171,271 units in total; 171,271 units in total; 171,271 units in total; 171,271 units in total; 171,271 units in total; 171,271 units in total; 171,271 units in total; 171,271 units in total; 171,271 units in total; 171,271 units in total; 171,271 units in total; 171,271 units in total; 171,271 units in total; 169,775 units in total; 169,775 units in total; 169,775 units in total; 169,775 units in total; 169,775 units in total; 169,775 units in total; 169,775 units in total; 169,775 units in total; 169,775 units in total; 169,775 units in total; 169,775 units in total; 169,775 units in total; 169,775 units in total; 169,775 units in total; 169,775 units in total)

Agency Last Updated: June 16, 2020

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Lots: N7L0306KX, N7M0221KX, N8B0724KX, N8C0958KX, N8C1303KRX GTIN # 1 (Inner Carton) -GTIN #1 10884523002812 GTIN # 2 (Outer Carton)- GTIN # 2 20884523002819

Lots: N7L0191KX, N7M0944KX, N8B0234KX,N8C0147KX GTIN # 1 (Inner Carton) - 10884523002836 GTIN # 2 (Outer Carton)- 20884523002833

Lots: N7D0492KRX, N7F0518KX, N7F0651KX, N7L0270KX, N7L0699KX, N7L0732KX, N7L1043KX, N8A0213KX, N8B0002KX, N8C0429KX GTIN # 1 (Inner Carton) - 10884523002881 GTIN # 2 (Outer Carton)- 20884523002888

Lot: N7G0756KX & N7L0819KX

Lot Numbers:

N7G0756KX

Lot: N7G0757KX GTIN # 1 (Inner Carton) - 10884521186095 GTIN # 2 (Outer Carton)- 20884521186092

Lot Numbers:

N7G0757KX

Lot: N7G0796KX & N7L0818KX

Lot Numbers:

N7G0796KX

Lot 0214062622

Lot Numbers:

0214062622

(1)Lot Number :0214710711 (2) Lot Number: 0214043771,0214232317,0214375093 (3) Lot Number: 0215113531,0215132607

Lot Numbers:

Number

Lot 0215227169

Lot Numbers:

0215227169

(1) Lot Number: 0214050554 (2) Lot Numbers: 0214907029,0214991119,0215130754,0215158268

Lot Numbers:

Number

Numbers

Lot Numbers: (1) 0214909888,0214916144 (2) 0215015272, 0215298205

Lot Numbers:

Numbers

Lot Numbers: 0213984473,0213583578,0213596057,0214068986, 0213589227

Lot Numbers:

Numbers

Lots 0214364763, 0214456590, 0214435328, 0214983139, 0215042012, 0215234651, 0215288296

Lots 0214915642, 0214983138, 0215159225, 0215234652

Lots 0214090852, 0214522213, 0215009132, 0215153445

Lots 0214049646, 0214370002, 0214470664, 0215208426

(1)Lot Number: 0214962218 (2) Lot Numbers: 02148663335, 0214993030, 0215178525

Lot Numbers:

Number

Numbers

Lot: 0214894171

Lot Numbers:

0214894171

Lot Numbers: (1) 0214463634, 0215280952 (2) 0214013887, 0214144177,0214260194,0214470767,0214956044 0214620382, 0214744957, 0215079103, 0215151206

Lot Numbers:

Numbers

Lot Numbers:

Numbers

Lot Numbers: (1) 0214049704, 0214529057, 0215176564 (2) 0215065486 (3) 0215017846 (4) 0215191012 (5) 0215218687

Lot Numbers:

Numbers

Lots: 0214930629, 0214993038, 0215068848, 0215124286, 0215124285, 0214793818, 0215130759,0215243237

(1) Lot: 0215082707, 0215176563 (2) Lot numbers: 0214993037,0214793817,0214930628 0214930630, 0215068849, 0215124284, 0215243236, 0214925902 0214925904, 0214925903, (3) Lot Number: 0215120700

Lot Numbers:

0215082707

numbers

Number

Lot: 0215124172, 0215253056

Lot Numbers:

0215124172

Lot Numbers: (1) 0214109631, 0214909770 (2) 0214975597 (3) 0214860061

Lot Numbers:

Numbers

Lot: 0215017845, 0215002541, 0215104507

Lot Numbers:

0215017845

Lots: 0215050309, 0215108007, 0215050310, 0215050308, 0215050311, 0215050312, 0215050313, 0215037144,0215037143, 0215108008

Lot Numbers: (1) 0215237526, 0214991351, 0214991350, 0215157998, 0215157997 (2) 0215237527, 0215282382, 0214991349, 0214991348, 0214991347

Lot Numbers:

Numbers

Lot: 0215244887

Lot Numbers:

0215244887

Lot Numbers: (1) 0215050387, 0215193250 (2) 0214933111 (3) 0214030210, 0215041719, 0215161529, 0215272924 (4) 0214985253, 0215104506 , 0215298203

Lot Numbers:

Numbers

Lot 0214726876

Lot Numbers:

0214726876

Lots: 0214874566, 0215001737, 0215151361

Lots: 0215122341, 0215226207

Lots:0215122344

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79974

Status: Resolved

Manufacturer: COVIDIEN MEDTRONIC

Manufactured In: United States

Agency Last Updated: June 16, 2020