Medtronic Recalls Endo GIA Stapler Kits Due to Missing Sled Component
Medtronic is recalling 171,271 Endo GIA stapler kits worldwide 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 risk of significant injury (bleeding or leakage of luminal contents) due to a structural defect in a medical device.
Plain-English summary
Medtronic is recalling 171,271 units of its "Best Practices" Procedure Kits containing Auto Suture Endo GIA Devices. The recall covers distribution in the United States and worldwide. The affected devices are surgical staplers used to place titanium staples and divide tissue.
The recall was initiated because the devices may be missing a sled component. This component is responsible for staple deployment. If the sled is missing, the device may fail to form a staple line when tissue is divided. This failure can lead to bleeding or the leakage of luminal contents.
Healthcare providers and facilities should check their inventory for the affected product codes and stop using the recalled devices. The source text does not specify specific actions for individual consumers, as these are professional medical devices.
The recalled product
- 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-s
- Manufacturer
- COVIDIEN MEDTRONIC
- Affected units
- 171,271
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)
- 00Z2403
- 00Z2293
- 00Z2200
- 00Z2745
- 00Z2650
- 00Z2648
- 00Z2429
- 00Z2287
- 00Z2117
- 00Z2482
- 00Z2582
- 00Z2096
- 00Z2273
- 00Z2544
- 00Z2577A
- 00Z2366
- 00Z2689
- 00Z2408
- 00Z2707
- SIGEVAL4
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
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- SevereMedtronic Endo GIA Reloads Recalled for Missing Sled Component
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- SevereMedtronic Tri-Staple 2.0 Reloads Recalled for Missing Sled Component
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- 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
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