FDA Medical Device Recalls (openFDA)
COVIDIEN MEDTRONIC: Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm Medium/Thick, Item Code SIG30AMT
- Recall number
- Z-2513-2018
- Recalling firm
- COVIDIEN MEDTRONIC
- Product
- Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm Medium/Thick, Item Code SIG30AMT
- Status
- Open, Classified
- Initiated
- 2018-05-22
- Posted
- 2018-07-19
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Process control
- Action
- On May 22, 2018, all U.S. consignees received an UPDATED URGENT MEDICAL DEVICE RECALL and RETURN FORM notice via Federal Express or certified. The initial notice was sent to impacted customers on April 26, 2018. Customers are advised to take the following required actions: 1. Immediately discontinue use, and quarantine affected products listed 2. Return affected product as indicated. 3. Complete the Recalled Product Return Form even if you do not have inventory and submit by either method below: * Product purchased directly from Medtronic: feedback.customerservice@Covidien.com or fax to (800) 895-6140. *Product purchased through distributor: FCAMITG@Covidien.com or fax it to (203) 492-7719.
- Quantity
- not on file
- Distribution
- 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
- Lot, serial or model codes
- N7L0915X & N7M0468X
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GDW
- Firm FEI
- 1219930
- Firm city
- NORTH HAVEN
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28