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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79974

40 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 26, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
COVIDIEN MEDTRONIC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

40 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 40

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 loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.

Z-1814-2018
Recall number
Z-1814-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
171,271 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Worldwide and US Nationwide

device · product 2 of 40

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.

Z-1815-2018
Recall number
Z-1815-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
171,271 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Worldwide and US Nationwide

device · product 3 of 40

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 loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.

Z-1816-2018
Recall number
Z-1816-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
171,271 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Worldwide and US Nationwide

device · product 4 of 40

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 loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.

Z-1817-2018
Recall number
Z-1817-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
171,271 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Worldwide and US Nationwide

device · product 5 of 40

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 unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.

Z-1818-2018
Recall number
Z-1818-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
171,271 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Worldwide and US Nationwide

device · product 6 of 40

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 loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.

Z-1819-2018
Recall number
Z-1819-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
171,271 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Worldwide and US Nationwide

device · product 7 of 40

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 loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.

Z-1820-2018
Recall number
Z-1820-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
171,271 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Worldwide and US Nationwide

device · product 8 of 40

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 the single use loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.

Z-1821-2018
Recall number
Z-1821-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
171,271 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot: N7G0756KX & N7L0819KX

Distribution pattern

Worldwide and US Nationwide

device · product 9 of 40

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 single use loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.

Z-1822-2018
Recall number
Z-1822-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
171,271 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Worldwide and US Nationwide

device · product 10 of 40

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 the single use loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.

Z-1823-2018
Recall number
Z-1823-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
171,271 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot: N7G0796KX & N7L0818KX

Distribution pattern

Worldwide and US Nationwide

device · product 11 of 40

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 sizes that are available in the 30 mm, 45 mm and 60 mm lines.

Z-1824-2018
Recall number
Z-1824-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
171,271 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Worldwide and US Nationwide

device · product 12 of 40

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, 45 mm and 60 mm lines.

Z-1825-2018
Recall number
Z-1825-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
171,271 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot 0214062622

Distribution pattern

Worldwide and US Nationwide

device · product 13 of 40

(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 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.

Z-1826-2018
Recall number
Z-1826-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
171,271 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Worldwide and US Nationwide

device · product 14 of 40

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 sizes that are available in the 30 mm, 45 mm and 60 mm lines.

Z-1828-2018
Recall number
Z-1828-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
171,271 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot 0215227169

Distribution pattern

Worldwide and US Nationwide

device · product 15 of 40

(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 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.

Z-1829-2018
Recall number
Z-1829-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
171,271 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Worldwide and US Nationwide

device · product 16 of 40

(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 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.

Z-1830-2018
Recall number
Z-1830-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
171,271 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Worldwide and US Nationwide

device · product 17 of 40

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 are available in the 30 mm, 45 mm and 60 mm lines.

Z-1831-2018
Recall number
Z-1831-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
171,271 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Worldwide and US Nationwide

device · product 18 of 40

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.

Z-1832-2018
Recall number
Z-1832-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
171,271 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Worldwide and US Nationwide

device · product 19 of 40

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.

Z-1833-2018
Recall number
Z-1833-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
171,271 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lots 0214915642, 0214983138, 0215159225, 0215234652

Distribution pattern

Worldwide and US Nationwide

device · product 20 of 40

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 mm lines.

Z-1834-2018
Recall number
Z-1834-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
171,271 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lots 0214090852, 0214522213, 0215009132, 0215153445

Distribution pattern

Worldwide and US Nationwide

device · product 21 of 40

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 mm, 45 mm and 60 mm lines.

Z-1837-2018
Recall number
Z-1837-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
171,271 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lots 0214049646, 0214370002, 0214470664, 0215208426

Distribution pattern

Worldwide and US Nationwide

device · product 22 of 40

(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 4.8 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.

Z-1838-2018
Recall number
Z-1838-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
171,271 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Worldwide and US Nationwide

device · product 23 of 40

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, 45 mm and 60 mm lines.

Z-1839-2018
Recall number
Z-1839-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
171,271 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot: 0214894171

Distribution pattern

Worldwide and US Nationwide

device · product 24 of 40

(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 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.

Z-1840-2018
Recall number
Z-1840-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
171,271 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Worldwide and US Nationwide

device · product 25 of 40

(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 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.

Z-1842-2018
Recall number
Z-1842-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
171,271 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Worldwide and US Nationwide

device · product 26 of 40

(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 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.

Z-1843-2018
Recall number
Z-1843-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
169,775 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Worldwide and US Nationwide

device · product 27 of 40

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 mm and 60 mm lines.

Z-1844-2018
Recall number
Z-1844-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
169,775 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Worldwide and US Nationwide

device · product 28 of 40

(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 loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.

Z-1847-2018
Recall number
Z-1847-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
169,775 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Worldwide and US Nationwide

device · product 29 of 40

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 and 60 mm lines.

Z-1848-2018
Recall number
Z-1848-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
169,775 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot: 0215124172, 0215253056

Distribution pattern

Worldwide and US Nationwide

device · product 30 of 40

(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 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.

Z-1849-2018
Recall number
Z-1849-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
169,775 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Worldwide and US Nationwide

device · product 31 of 40

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.

Z-1850-2018
Recall number
Z-1850-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
169,775 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot: 0215017845, 0215002541, 0215104507

Distribution pattern

Worldwide and US Nationwide

device · product 32 of 40

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 lines.

Z-1852-2018
Recall number
Z-1852-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
169,775 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Worldwide and US Nationwide

device · product 33 of 40

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 and 60 mm lines.

Z-1854-2018
Recall number
Z-1854-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
169,775 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Worldwide and US Nationwide

device · product 34 of 40

(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 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.

Z-1855-2018
Recall number
Z-1855-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
169,775 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Worldwide and US Nationwide

device · product 35 of 40

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 and 60 mm lines.

Z-1858-2018
Recall number
Z-1858-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
169,775 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot: 0215244887

Distribution pattern

Worldwide and US Nationwide

device · product 36 of 40

(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 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.

Z-1859-2018
Recall number
Z-1859-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
169,775 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Worldwide and US Nationwide

device · product 37 of 40

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 and 60 mm lines.

Z-1862-2018
Recall number
Z-1862-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
169,775 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot 0214726876

Distribution pattern

Worldwide and US Nationwide

device · product 38 of 40

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 lines.

Z-1863-2018
Recall number
Z-1863-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
169,775 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lots: 0214874566, 0215001737, 0215151361

Distribution pattern

Worldwide and US Nationwide

device · product 39 of 40

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 60 mm lines.

Z-1865-2018
Recall number
Z-1865-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
169,775 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lots: 0215122341, 0215226207

Distribution pattern

Worldwide and US Nationwide

device · product 40 of 40

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 lines.

Z-1866-2018
Recall number
Z-1866-2018
Initiated
April 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN MEDTRONIC
Quantity
169,775 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lots:0215122344

Distribution pattern

Worldwide and US Nationwide