Device recall: Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has…
Class II FDA enforcement event 82426. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Sterilization method used was not consistent with the labeling and the approved sterilization method
Class II, in the words of FDA
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
COVIDIEN LLC started this device recall on 13 Mar 2019. The firm address in the FDA record is in Mansfield, MA. FDA put the recall in Class II. FDA event 82426 has 3 product records. The first FDA enforcement report date is 1 May 2019. The record gives the status Terminated, with the termination date 23 Apr 2020.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution: US (Nationwide) and to countries of: Canada, Chile, Costa Rica, Guatemala, Japan, Mexico, Panama, Slovakia, Spain, Switzerland and Turkey.
Recalling firm
COVIDIEN LLC, Mansfield, MA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
3 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1211-2019 | Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has a 5 mm diameter, rotating, insulated shaft approximately 31 cm in length and is designed for introduction and use through the appropriately sized Covidien" trocar sleeve or larger sized sleeve with… | 7248 units | Class II | Terminated | 1 May 2019 |
| Z-1212-2019 | Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument has applications in a variety of gynecologic, general, urologic, thoracic and endoscopic procedures for temporary grasping/clamping of tissue and small tubular structures. | 240 units | Class II | Terminated | 1 May 2019 |
| Z-1213-2019 | Procedure kits include devices from the affected lots distributed OUS only: (1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO (2)BOX KIT00680 KIT COLECISTECTOMIA- (3)BOX KIT00681 KIT APENDICECTOMIA (4)BOX KIT00897 KIT COLON IZQUIERDO (5)BOX LAPL1 ZESTAW DO CHOLECYSTEKTOMII (6)BOX PST01134 LAP CHOLE KIT ST JOHN S… | 148 units | Class II | Terminated | 1 May 2019 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2019
- 968
- Share of these events in Class II
- 88%
- Product records in this event
- 3Median of the firm: 1
- Events of the firm on the register
- 77
Other events of the firm
Official channels
- FDA enforcement report Z-1211-2019The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 82426. https://recallregister.com/fda/ii/82426/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution: US (Nationwide) and to countries of: Canada, Chile, Costa Rica, Guatemala, Japan, Mexico, Panama, Slovakia, Spain, Switzerland and Turkey.
- What quantity of product is in FDA event 82426?
- The event has 3 product records. The first record gives this quantity:
7248 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2019 have the same class?
- 88% of the 968 device events that started in 2019 are in Class II.