Covidien Llc Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - 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). Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - 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).
Brand
Covidien Llc
Lot Codes / Batch Numbers
Lots P9J0241Y P9J0242Y P9J0243Y P9K1140Y P9K1663Y P9K1141Y
Products Sold
Lots P9J0241Y P9J0242Y P9J0243Y P9K1140Y P9K1663Y P9K1141Y
Covidien Llc is recalling Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Product Usage: has applica due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
All consignees were notified by letter titled "Urgent Medical Device Recall" delivered via Federal Express and/or certified mail beginning May 12, 2020. The letter informs customers of the recall of specific item codes and production lots of Multifire hernia staplers due to a manufacturing assembly error. Use of a device with this condition may result in the failure of staples to properly advance within the staple cartridge when the instrument handle is compressed. Customers are instructed to take the following actions: " Immediately quarantine and discontinue use of the affected item code and lot. " Return affected product. " Promptly forward the information from the customer communication to any recipients to whom they have distributed any of the affected product. " Complete the Recalled Product Return Form even if you do not have inventory. If you have any questions about this event, you may contact Medtronic via email at rs.assurancequality@medtronic.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026