Medtronic Endo GIA Reloads Recalled for Missing Sled Component
Medtronic is recalling specific Endo GIA 60 mm reloads because a missing sled component may prevent staple formation, potentially causing 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 the source text explicitly states that the defect may lead to bleeding or leakage of luminal contents, which aligns with the rubric criteria for a Severe rating involving significant injury reports or potential.
Plain-English summary
Medtronic is recalling the Endo GIA 60 mm Extra Thick Black Articulating Reload with Tri-Staple Technology (Item Code EGIA60AXT) due to a potential manufacturing defect. The recall covers specific lot codes N7L0974KX, N7M0486KX, N7M0762KX, and N8A0363KX. The affected devices were distributed nationwide in the United States and internationally to numerous countries, including those in Europe, the Middle East, Africa, and Asia.
The recall is issued because the device may be missing a sled component, which is responsible for staple deployment. If the sled is missing, the device may fail to form a staple line when tissue is divided during a surgical procedure. This failure could lead to bleeding or the leakage of luminal contents.
Healthcare providers and facilities should check their inventory for the specific item code and lot numbers listed in this recall. If the affected devices are found, they should be removed from use and returned to Medtronic according to the company's instructions. Patients who have had procedures using these devices should contact their healthcare provider if they experience complications.
The recalled product
- Product
- Endo GIA 60 mm Extra Thick Black Articulating Reload with Tri-Staple Technology, Item Code EGIA60AXT
- 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 (3)
- N7L0974KX
- N7M0486KX
- N7M0762KX & N8A0363KX
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 →- 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
- SevereMedtronic Tri-Staple 2.0 Reloads Recalled for Missing Sled Component
FDA (Devices) · 2018-07-25
- SevereMedtronic Endo GIA Stapler Recall Due to Missing Sled Component
FDA (Devices) · 2018-07-25
- SevereEndo GIA 60 mm Articulating Vascular/Medium Loading Unit Recalled for Missing Sled
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