PlainRecalls
FDA Devices Moderate Class II Ongoing

Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Part No. 174027 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).

Reported: June 10, 2020 Initiated: May 12, 2020 #Z-2255-2020

Product Description

Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Part No. 174027 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).

Reason for Recall

The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compressed.

Details

Recalling Firm
Covidien Llc
Units Affected
12,610 total
Distribution
Worldwide distribution.
Location
Mansfield, MA

Frequently Asked Questions

What product was recalled?
Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Part No. 174027 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).. Recalled by Covidien Llc. Units affected: 12,610 total.
Why was this product recalled?
The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compressed.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 10, 2020. Severity: Moderate. Recall number: Z-2255-2020.