Medtronic Tri-Staple 2.0 Reloads Recalled for Missing Sled Component
Medtronic is recalling Tri-Staple 2.0 Intelligent Reloads because a missing sled component may prevent staple formation, leading to bleeding or leakage.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect that may lead to significant injury (bleeding or leakage of luminal contents), meeting the criteria for a Severe rating.
Plain-English summary
Medtronic is recalling Tri-Staple 2.0 Intelligent Reloads for use with the Signia stapling system (30 mm Medium/Thick, Item Code SIG30AMT). The recall affects specific lot codes N7L0915X and N7M0468X.
The device may be missing a sled component, which is responsible for staple deployment. This defect may result in the failure to form a staple line when tissue is divided, potentially leading to bleeding or leakage of luminal contents.
The affected products were distributed nationwide in the U.S. and internationally to numerous countries including Albania, Algeria, Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hungary, Iceland, Ireland, Israel, Italy, Ivory Coast, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Malta, Martinique, Moldova, Morocco, Namibia, Netherlands, New Caledonia, Norway, Pakistan, Poland, Portugal, Reunion, Romania, Russian federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, and the United Kingdom.
The recalled product
- Product
- Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm Medium/Thick, Item Code SIG30AMT
- Manufacturer
- COVIDIEN MEDTRONIC
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- N7L0915X & N7M0468X
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 14 recalled by COVIDIEN MEDTRONIC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 14 products in this recall →Related recalls
Same manufacturer · COVIDIEN MEDTRONIC
See all →- SevereEndo GIA 60 mm Articulating Vascular/Medium Loading Unit Recalled for Missing Sled
FDA (Devices) · 2018-07-25
- SevereMedtronic Tri-Staple 2.0 Curved Tip Intelligent Reload Recall for Missing Sled
FDA (Devices) · 2018-07-25
- SevereMedtronic Endo GIA Stapler Recall Due to Missing Sled Component
FDA (Devices) · 2018-07-25
- SevereMedtronic Endo GIA Vascular Reloads Recalled for Missing Sled Component
FDA (Devices) · 2018-07-25
- SevereMedtronic Endo GIA Reloads Recalled for Missing Sled Component
FDA (Devices) · 2018-07-25
Same hazard · bleeding
See all →- HighHollister Recalls Onli Hydrophilic Urethral Catheters Due to Manufacturing Defect
FDA (Devices) · 2026-09-02
- SevereCannon II Plus Hemodialysis Catheter Recall Due to Sheath Introducer Defect
FDA (Devices) · 2026-05-20
- SevereArrow-Clark VectorFlow Hemodialysis Catheters with Defective Sheath Introducer
FDA (Devices) · 2026-05-20
- SevereNextStep Hemodialysis Catheters with Defective Sheath Introducer
FDA (Devices) · 2026-05-20
- SevereArrow Edge hemodialysis kits contain a sheath introducer that may not split
FDA (Devices) · 2026-05-20