CLASS II Device recall · Reported 11 Feb 2015 · FDA Enforcement Report
Lubricated Intubating Stylet that is inserted into recalled
Cardinal Health is recalling Lubricated Intubating Stylet that is inserted into an endotracheal tube to facilitate, distributed nationwide in the US. The recall was initiated on 23 Dec 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1054-2015
- FDA event ID
- 70185
- Recalling firm
- Cardinal Health, Waukegan, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Dec 2014
- FDA classified
- 4 Feb 2015
- Reported
- 11 Feb 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 23 Dec 2014 | Recall initiated by company | |
| 4 Feb 2015 | Classified by FDA | +43 days |
| 11 Feb 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
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
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Why was it recalled?
A small piece of the stylet sheath has the potential to shear off upon removal of the stylet from the tracheal tube.
Which lots are affected?
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
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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