Food, drugs, devices › Covidien LLC
Device recall: Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have applicat
Covidien LLC (North Haven, CT) initiated this device recall on 15 Sep 2017; FDA lists 1 product record under event 79166, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 19 Dec 2018. Initiation: voluntary: firm initiated. Covidien LLC has 77 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Covidien LLC, North Haven, CT.
Reason for recall
"The device cartridge disengaged during use due to manufacturing error."
Distribution
"Internationally, including Japan. No USA Customers"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0908-2018 | Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gynecologic and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis,… | 163 | Class II | Terminated | 14 Mar 2018 |
Context
Other enforcement events for Covidien LLC
All 77 events for Covidien LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The device cartridge disengaged during use due to manufacturing error."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Internationally, including Japan. No USA Customers"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 19 Dec 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.