Lubricated Intubating Stylet 6FR that is inserted into an… — Class II medical device recall Z-1054-2015
Terminated recall by Cardinal Health, reported 2015-02-11, distributed nationwide. A small piece of the stylet sheath has the potential to shear off upon removal of the stylet from the tracheal
| Recall number | Z-1054-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health, Waukegan, IL, United States |
| Recall initiated | 2014-12-23 |
| Classified | 2015-02-04 |
| Reported by FDA | 2015-02-11 |
| Terminated | 2016-08-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | KR |
| Quantity | 104,432 stylets |
| Lot numbers | 1003020386-SH, 1104LS04A-SH, 1105LS05A-SH, 1106LS06A-SH, 1107LS07A-SH, 1110LS10A-SH, 1111LS11A-SH, 1204LS03A-SH, 1303LS04A-SH, 1307LS14A-SH, 1308LS17A-SH, 1310LS21A-SH, 1310LS23A-SH, 1404LS14A-SH, 1406LS22A-SH, 1408LS41A-SH, 1409LS45A-SH, 907021095-SH, 910021815-SH, 912022138-SH |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1054-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.