Teleflex Recalls Sheridan Cuffed Tracheal Tubes Due to Labeling Inconsistency
Teleflex Medical is recalling Sheridan cuffed tracheal tubes because some units are labeled with incorrect sizes, potentially leading to improper airway management.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a labeling error on a medical device used for airway management, which poses a risk of harm if an incorrectly sized tube is used, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Teleflex Medical is recalling Sheridan/CF and Sheridan/HVT cuffed tracheal tubes, catalog numbers 5-10114 and 5-10315. The recall involves 25,274 units from lots 73A1500461 and 73D1400082. These medical devices are used to insert into a patient's mouth or nose for airway management.
The recall is due to a labeling inconsistency where units labeled as 7mm tubes may actually contain 6.5mm tubes, and units labeled as 7.5mm tubes may contain 5.5mm tubes. This discrepancy could result in the use of an incorrectly sized tube for a patient's airway.
The affected units were distributed worldwide, including in the United States and internationally to Canada, Chile, and Japan. Healthcare providers and facilities should check their inventory for these specific catalog numbers and lot numbers. If found, the devices should be removed from use and returned to Teleflex Medical for credit or replacement.
The recalled product
- Product
- Sheridan/CF, Cuffed Tracheal Tube, Catalog # 5-10114 and Sheridan/HVT Cuffed Tracheal Tube, Catalog # 5-10315 A tracheal tube is inserted into a patients mouth or nose for airway management
- Manufacturer
- Teleflex Medical
- Affected units
- 25,274
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 (1)
- Lots 73A1500461 & 73D1400082
Distribution
Related recalls
Same manufacturer · Teleflex Medical
See all →- LowTeleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
- LowTeleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
- ModerateTeleflex Sheridan Endobronchial Tubes Recalled for Incorrect Labeling
FDA (Devices) · 2019-12-25
- HighTeleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25
- HighTeleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02