FDA Devices recall · Reported February 11, 2015
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.
A small piece of the stylet sheath has the potential to shear off upon removal of the stylet from the tracheal tube.
Cardinal Health recalled Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate… - a moderate-severity action.
Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate… was recalled by Cardinal Health in February 11, 2015. Reason: A small piece of the stylet sheath has the potential to shear off upon removal of the stylet from the trache…. Check the official notice for the remedy. Verify recall #Z-1054-2015 with the FDA Devices before acting.
The recall
Cardinal Health issued this moderate-severity FDA Devices recall-A small piece of the stylet sheath has the potential to shear off upon removal of the stylet from the trache….
- Moderate
- severity level
- Class II
- classification
- February 11, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1054-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1054-2015) was formally reported on February 11, 2015, with the manufacturer initiating the action on December 23, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Cardinal Health is listed as the recalling firm, operating out of Waukegan, IL. Federal records list the affected scope as 104,432 stylets.
The documented reason for this recall is: A small piece of the stylet sheath has the potential to shear off upon removal of the stylet from the tracheal tube. Distribution data in the federal record shows the product reached: 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 +…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1054-2015 |
| Date reported | February 11, 2015 |
| Date initiated | December 23, 2014 |
| Recalling firm | Cardinal Health |
| Firm location | Waukegan, IL |
| Affected scope | 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… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1054-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Similar severity · nearest report date
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Methodology · Corrections · Archive as of August 2026