Endo GIA 45 mm Articulating Medium/Thick Reload Recalled for Missing Sled Component
COVIDIEN MEDTRONIC is recalling Endo GIA 45 mm Articulating Medium/Thick 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 risk of significant injury, specifically bleeding or leakage of luminal contents, which aligns with the 'Severe' rubric criteria for significant injury reports or high-risk device defects.
Plain-English summary
COVIDIEN MEDTRONIC is recalling the Endo GIA 45 mm Articulating Medium/Thick Reload with Tri-Staple Technology, Item Code EGIA45AMT. The recall is due to a potential defect where the device may be missing a sled component. This component is responsible for staple deployment.
If the sled component is missing, the device may fail to form a staple line when tissue is divided. This failure can lead to bleeding or leakage of luminal contents. The affected products were distributed nationwide in the U.S.A. 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 & United Kingdom.
The specific lot codes affected are N7L0521KX, N7M0047KX, N7M0592KX, N7M1001KX, N7L0975KX, N7M0434KX, N7M0683KX, N8A0203KX, N7L1057KX, N7M0528KX, N7M0937KX, N8A0677KX, N7L1098KX, N7M0529KX, N7M0949KX, N8C0144KX & N7L1099KX. Healthcare providers and facilities should check their inventory for these specific item codes and stop using the affected devices if they are present.
The recalled product
- Product
- Endo GIA 45 mm Articulating Medium/Thick Reload with Tri-Staple Technology, Item Code EGIA45AMT
- 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 (16)
- N7L0521KX
- N7M0047KX
- N7M0592KX
- N7M1001KX
- N7L0975KX
- N7M0434KX
- N7M0683KX
- N8A0203KX
- N7L1057KX
- N7M0528KX
- N7M0937KX
- N8A0677KX
- N7L1098KX
- N7M0529KX
- N7M0949KX
- N8C0144KX & N7L1099KX
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
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See all →- SevereMedtronic Endo GIA Vascular 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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- SevereEndo GIA 60 mm Articulating Vascular/Medium Loading Unit Recalled for Missing Sled
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