Z-1054-2015Class II

Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation. This...

Name: Z-1054-2015 Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation. This...
Creator: Cardinal Health
Published: 2014-12-23
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2014-12-23 / Terminated / root cause: manufacturing process

FDA source

Cardinal Health began a recall of Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation. This product is used in surgical or medical emergency... on 2014-12-23. FDA classified it as Class II and gives the reason as "A small piece of the stylet sheath has the potential to shear off upon removal of the stylet from the tracheal tube". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1054-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-23
Posted: 2015-02-04
Terminated: 2016-08-01
Recalling firm: Medtronic, Inc.
Product: Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation. This product is used in surgical or medical emergency facilities. Primarily used on infants and pediatric patients.
Product code: BSR Stylet, Tracheal Tube
Reason for recall: A small piece of the stylet sheath has the potential to shear off upon removal of the stylet from the tracheal tube.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: URGENT: PRODUCT RECALL letters dated December 23, 2014 were sent to all customers of record. The letters included instructions for customers to: 1) quarantine the affected product; 2) notify any customers whom you may have distributed the affected product to; 3) contact the appropriate Customer Service group to arrange for return and credit of any affected product in your inventory; and, 4) complete and return the enclosed Acknowledgement Form. Customers with questions about this recall can contact Cardinal Health Quality Systems at 800-292-9332.
Quantity in commerce: 104,432 stylets
Distribution: US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV, WY) + District of Columbia + Guam + US Army Facility in South Korea
Product codes and lots: Material Number: ISL6; Lot Numbers: 1409LS45A-SH, 1408LS41A-SH, 1406LS22A-SH, 1404LS14A-SH, 1310LS23A-SH, 1310LS21A-SH, 1308LS17A-SH, 1307LS14A-SH, 1303LS04A-SH, 1204LS03A-SH, 1110LS10A-SH, 1111LS11A-SH, 1107LS07A-SH, 1106LS06A-SH, 1104LS04A-SH, 1105LS05A-SH, 1003020386-SH, 912022138-SH, 910021815-SH, 907021095-SH

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1054-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1054-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-11	2015-02-04

Product code BSR

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)