Z-1610-2010

Disposable Skin Stapler - 35 Wide; Surgical Skin Stapler; Rx, sterile, single use skin stapler, individually...

Name: Z-1610-2010 Disposable Skin Stapler - 35 Wide; Surgical Skin Stapler; Rx, sterile, single use skin stapler, individually...
Creator: Cardinal Health
Published: 2010-04-01
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2010-04-01 / Terminated / root cause: packaging

FDA source

Cardinal Health began a recall of Disposable Skin Stapler - 35 Wide; Surgical Skin Stapler; Rx, sterile, single use skin stapler, individually packaged in a thermo-formed tray with a Tyvek lid... on 2010-04-01. The reason FDA records is "The sterility of the staplers is questionable". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1610-2010
Status: Terminated
Initiated: 2010-04-01
Posted: 2010-05-19
Terminated: 2011-08-17
Recalling firm: Medtronic, Inc.
Product: Disposable Skin Stapler - 35 Wide; Surgical Skin Stapler; Rx, sterile, single use skin stapler, individually packaged in a thermo-formed tray with a Tyvek lid, 5 trays per box; Distributed by Cardinal Health, Dublin, OH 43017, Made in China; catalog number FS-35W. Designed to close incisions during a surgical procedure.
Product code: GAG Stapler, Surgical
Reason for recall: The sterility of the staplers is questionable.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Cardinal Health issued an "Urgent: Product Recall" letter dated April 1, 2010 to all customers who may have received affected product. Customers were instructed to immediately quarantine any affected inventory, return the notification acknowledgement form and return the product to the firm. For further information, contact Cardinal Health Customer Service at 1-888-444-5440.
Quantity in commerce: 1,638 units
Distribution: Nationwide Distribution
Product codes and lots: Catalog Number: FS-35W, Lot Numbers: 090203-SH and 091008-SH.

Product code GAG

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)