Tracheostomy Tubes Recalled for Manufacturing Defect Affecting Securement Flange
Smiths Medical recalled specific lots of PORTEX Bivona Tracheostomy Tubes due to a manufacturing defect that may cause the securement flange to tear. Affected products were distributed worldwide.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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: FDA Class I classification mandates a minimum severity of 4 per the recall rubric. The manufacturing defect affects a critical airway device where structural failure could compromise patient safety.
Plain-English summary
Smiths Medical recalled specific lots of the PORTEX Bivona Tracheostomy Tubes, medical devices used to maintain open airways in patients requiring breathing assistance. Four product codes are affected: 65N025, 65N030, 65N035, and 65N040, with specific lot numbers identified in the FDA recall notice.
The recall was prompted by identification of a manufacturing defect in which the securement flange—the part that holds the tube in place—may tear. A flange failure could compromise the tube's ability to remain properly secured.
These tubes were distributed worldwide. Patients, caregivers, and healthcare facilities should verify whether they have any of the affected lots by checking the product code and lot number against the FDA recall information. Healthcare providers should be contacted if a patient is currently using an affected device.
The recalled product
- Product
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N025; b) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N030; c) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code…
- Manufacturer
- Smiths Medical ASD Inc.
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)
- a) UDI/DI 15021312005905
- Product Code/List Number/Item Code 65N025
- Lot Numbers: 3949029
- 4138994
- 4171564
- 4334857
- 4383590
- b) UDI/DI 15021312005912
- Product Code/List Number/Item Code 65N030
- Lot Numbers: 3917999
- 3965333
- 4142429
- 4161978
- 4185397
- 4197598
- 4334858
- 4348373
- c) UDI/DI 15021312005929
- Product Code/List Number/Item Code 65N035
- Lot Numbers: 3871033
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 28 recalled by Smiths Medical ASD Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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