Cardinal Health: Medical Device Recall in 2015 - (Recall #: Z-1054-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: December 23, 2014

Date Posted: February 11, 2015

Recall Number: Z-1054-2015

Event ID: 70185

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.

Status: Terminated

Product Quantity: 104,432 stylets

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated