FDA Warns That Stolen Covidien Stapler Reloads Not Sterile

In short

One of our more bizarre news items in recent times concerns the FDA issuing a warning to healthcare professionals that stolen Covidien stapler reloads may be in circulation. The reloads are labelled sterile, but were stolen from the company prior to sterilisation taking place.


The FDA issued its warning this week to surgical clinicians, hospital and ambulatory surgery center managers, operating room managers and inventory management personnel. The specific devices in question are Covidien Endo GIA Articulating 60-3.5 Surgical Stapler Reloads with lot number N3B0165LX, some of which have apparently already been offered for sale.

The Covidien surgical stapler reloads, used in abdominal, gynecologic, pediatric and thoracic surgery and use of these non-sterile products could increase the risk of infection in surgical patients.

Customers are being asked to check the Reference Code and the Lot Number on every box of Covidien Surgical Stapler Reloads prior to use, quarantine any questionable lots and notify Covidien immediately. Furthermore the FDA is suggesting that medical devices in general should be purchased from trusted and reliable sources such as the manufacturer or authorized distributors, and not from online auction sites.

Source: FDA