Medtronic Endo GIA Staplers Recalled for Missing Sled Component
Medtronic is recalling Endo GIA staplers 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 defect that can lead to significant injury, specifically bleeding or leakage of luminal contents.
Plain-English summary
Medtronic is recalling specific lots of Endo GIA universal and Endo GIA universal XL staplers. The recall involves 169,775 units distributed worldwide and in the US.
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.
Healthcare providers should check their inventory for the affected lot numbers and stop using the recalled devices. Consumers are not expected to have these professional medical devices in their homes.
The recalled product
- 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
- Manufacturer
- COVIDIEN MEDTRONIC
- Affected units
- 169,775
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 (20)
- Lots: 0214860061
- 0215036240
- 0215036239
- 0215036238
- 0215018854
- 0215018855
- 0215102248
- 0215102247
- 0215068747
- 0215068748
- 0215050427
- 0215102246
- 0215050429
- 0215050428
- 0215068746
- 0215117409
- 0215117411
- 0215117410
- 0215125963
- 0215125962
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 40 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 40 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