CLASS II ONGOING Device recall · Reported 25 Jul 2018 · FDA Enforcement Report
Endo GIA Gray Articulating Vascular Reload recalled
Covidien Medtronic is recalling Endo GIA Gray Articulating Vascular Reload with Tri-Staple Technology, distributed nationwide in the US. The recall was initiated on 22 May 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2509-2018
- FDA event ID
- 80423
- Recalling firm
- Covidien Medtronic, NORTH HAVEN, CT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 May 2018
- FDA classified
- 19 Jul 2018
- Reported
- 25 Jul 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 22 May 2018 | Recall initiated by company | |
| 19 Jul 2018 | Classified by FDA | +58 days |
| 25 Jul 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Endo GIA 45mm Gray Articulating Vascular Reload with Tri-Staple Technology, Item Code EGIA45AV
Where it was distributed
Nationwide U.S.A. Internationally to: 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
Questions about this recall
Is Endo GIA Gray Articulating Vascular Reload with Tri-Staple Technology recalled?
Yes. Covidien Medtronic recalled Endo GIA Gray Articulating Vascular Reload with Tri-Staple Technology on 22 May 2018. The recall is Class II and its status is Ongoing. Recall number Z-2509-2018.
Why was it recalled?
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Which lots are affected?
N7L0823KX, N8A0799KX & N8B1008KX
Where was it sold?
Nationwide U.S.A. Internationally to: 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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Covidien Medtronic
All 55| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Tri-Staple 0 Black Intelligent Reload for use recalled | Covidien Medtronic | Packaging Defects | Nationwide |
| Device | CLASS II | Endo GIA Curved Tip Articulating Vascular/Medium Reload recalled | Covidien Medtronic | Packaging Defects | Nationwide |
| Device | CLASS II | Tri-Staple 0 Intelligent Reload for use recalled by Covidien Medtronic | Covidien Medtronic | Packaging Defects | Nationwide |
| Device | CLASS II | Tri-Staple 0 Curved Tip Intelligent Reload for use recalled | Covidien Medtronic | Packaging Defects | Nationwide |
| Device | CLASS II | Endo GIA Extra Thick Black Articulating Reload recalled | Covidien Medtronic | Packaging Defects | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |