Z-2254-2020Class II

Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part No. 174025 -

Name: Z-2254-2020 Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part No. 174025 -
Creator: Covidien Llc
Published: 2020-05-12
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2020-05-12 / Open, Classified / root cause: manufacturing process

FDA source

Covidien Llc began a recall of Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part No. 174025 - Product Usage: has application in endoscopic general surgery... on 2020-05-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2254-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-05-12
Posted: 2020-06-03
Recalling firm: Medtronic, Inc.
Product: Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part No. 174025 - 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).
Product code: GCI Laryngoscope, Endoscope
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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 [email protected]
Quantity in commerce: 12,610 total
Distribution: Worldwide distribution.
Product codes and lots: Lots P9J1171Y P9K1395Y P9K1582Y

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2254-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2252-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-10	2020-06-03
Z-2253-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-10	2020-06-03
Z-2254-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-10	2020-06-03
Z-2255-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-10	2020-06-03

Product code GCI

K912097Class IIAuto Suture Endoscopic Fascia StaplerUnited States Surgical, A Division of Tyco Healthc / cleared 1991-09-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)