Teleflex Recalls Sheridan Cuffed Tracheal Tubes Due to Labeling Error
Teleflex Medical is recalling 14,000 Sheridan/CF Cuffed Tracheal Tubes because the label indicates size 8mm but the tube may be size 7.5mm.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error regarding the size of the medical device, which fits the criteria for moderate severity.
Plain-English summary
Teleflex Medical is recalling 14,000 units of Sheridan/CF Cuffed Tracheal Tubes, sterile, prescription only. The product is designed for oral and nasal intubation and is indicated for airway management. The recall is due to a product labeling error where the units from the affected lot indicate that they contain a size 8mm tracheal tube, but they may actually contain a size 7.5mm tracheal tube.
The affected product is identified by Product Code 5-10116 and Lot number 01A1400211. The units were distributed worldwide, including in the U.S., Belgium, Canada, and Japan.
Healthcare providers and consumers should stop using the affected tracheal tubes and contact Teleflex Medical for further instructions or a replacement.
The recalled product
- Product
- Sheridan/CF Cuffed Tracheal Tube, Sterile, Rx only, Teleflex Medical, Research Triangle Park, NC 27708. Designed for oral and nasal intubation and are indicated for airway management.
- Manufacturer
- Teleflex Medical
- Hazard
- Affected units
- 14,000
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 (2)
- Product Code: 5-10116
- Lot number: 01A1400211
Distribution
Distribution scope not specified by the agency.
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 →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- HighTeleflex Recalls Sheridan Cuffed Tracheal Tubes Due to Labeling Inconsistency
FDA (Devices) · 2017-02-15
- ModerateTeleflex Recalls Sterile Tracheal Tubes Due to Size Labeling Error
FDA (Devices) · 2016-06-15
- SevereTeleflex Recalls Sheridan/CF Novaplus Tracheal Tubes Due to Connector Disconnection
FDA (Devices) · 2019-09-18
- ModerateTeleflex Recalls Preformed Tracheal Tubes Due to Incorrect Labeling
FDA (Devices) · 2015-02-18
- CriticalTeleflex Medical Recalls Sheridan Preformed Tracheal Tubes Due to Disconnection Risk
FDA (Devices) · 2019-09-18
- SevereTeleflex Medical Recalls Hudson RCI Sheridan Tracheal Tubes
FDA (Devices) · 2019-06-26