Cardinal Health Recalls Lubricated Intubating Stylets Due to Shear Risk
Cardinal Health is recalling 104,432 Lubricated Intubating Stylets 6FR because a small piece of the sheath may shear off during removal, posing a risk to infants and pediatric patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential foreign object in the airway of vulnerable pediatric patients, which constitutes a significant injury risk, aligning with the 'Severe' criteria for significant injury reports or high-risk device defects.
Plain-English summary
Cardinal Health is recalling 104,432 units of Lubricated Intubating Stylets 6FR. These medical devices are inserted into endotracheal tubes to facilitate intubation and are primarily used on infants and pediatric patients in surgical or medical emergency facilities.
The recall was initiated because a small piece of the stylet sheath has the potential to shear off upon removal of the stylet from the tracheal tube. This defect could result in a foreign object remaining in the patient's airway.
The affected products were distributed nationwide across the United States, including the District of Columbia, Guam, and a US Army facility in South Korea. Healthcare facilities should stop using the affected stylets and contact Cardinal Health for further instructions.
The recalled product
- 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.
- Manufacturer
- Cardinal Health
- Affected units
- 104,432
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Related recalls
Same manufacturer · Cardinal Health
See all →- HighDover Closed Urethral Tray Recalled for Potential Drainage Blockage Risk
FDA (Devices) · 2022-12-14
- HighDover Urethral Catheter Drainage System Recall for Potential Port Blockage
FDA (Devices) · 2022-12-14
- HighDover Urinary Catheter Drainage Tray Recall Due to Blockage Risk
FDA (Devices) · 2022-12-14
- HighDover Closed Urethral Tray Recalled Due to Drainage Port Blockage Risk
FDA (Devices) · 2022-12-14
- HighDover urinary catheter drainage bag occlusion defect nationwide recall
FDA (Devices) · 2022-12-14
Same hazard · foreign object
See all →- ModerateMezzetta Golden Greek Peperoncini Recalled for Potential Mouse Contamination
FDA (Food) · 2026-10-14
- SevereUnited and Good & Gather Light Brown Sugar Recalled for Wheat Contamination
FDA (Food) · 2026-09-30
- SevereBaxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-09-16
- ModerateBionpharma Recalls Doxylamine Succinate Tablets Due to Foreign Material Presence
FDA (Drugs) · 2026-09-09
- SevereTeva Recalls Trazodone Hydrochloride Tablets Due to Foreign Material
FDA (Drugs) · 2026-09-09
Similar recalls
- HighCardinal Health Recalls Enteral Infusion Pumps Due to Air Risk
FDA (Devices) · 2021-04-14
- LowTeleflex Recalls Sheridan Intubating Stylets Due to Incorrect Size Labeling
FDA (Devices) · 2017-06-21
- HighCareFusion LightWand Stylet Recalled for Sterile Packaging Breach Risk
FDA (Devices) · 2015-05-06
- ModerateCardinal Health Recalls Mislabeled Sterile Surgical Drapes
FDA (Devices) · 2017-08-02
- SevereCardinal Health Recalls Presource Shoulder Arthroscopy Kits Due to Airflow Obstruction Risk
FDA (Devices) · 2013-05-15
- ModerateCardinal Health Recalls Kendall Spill Kits Due to Gown Defects
FDA (Devices) · 2021-02-17