Smiths Medical Bivona Tracheostomy Tubes Recalled for Flange Tear Risk
Smiths Medical is recalling PORTEX Bivona Tracheostomy Tubes due to a manufacturing defect that may cause the securement flange to tear. Affected lots include neonatal, pediatric, and adult sizes distributed worldwide with 177,340 units impacted.
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 recall classification establishes a minimum severity score of 4. No reported illnesses, injuries, or deaths are documented in the source, which prevents elevation to Critical (5). The defect involves a critical airway device component, warranting Severe classification.
Plain-English summary
Smiths Medical ASD Inc. is recalling specific lots of PORTEX Bivona Tracheostomy Silicone Tubes (7.0mm and 8.0mm sizes with tight-to-shaft cuffs) due to a manufacturing defect. The securement flange on affected units may tear, potentially compromising the tube's attachment to the patient.
The defect affects 177,340 units distributed worldwide. Two product variants are included: the 7.0mm TTS Tracheostomy Tube (Product Code 670170) and the 8.0mm TTS Tracheostomy Tube (Product Code 670180). Multiple lot numbers spanning production periods are affected, as detailed by the manufacturer.
Healthcare providers and patients who use these devices should immediately check whether their products are from the affected lots using the manufacturer's lot number listings. If a product is on the recall list, discontinue use and contact Smiths Medical for a replacement. Patients who have used affected devices and experienced any complications should consult their healthcare provider.
The recalled product
- Product
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 177,340
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 15021312006056. Product Code/List Number/Item Code 670170
- Lot Numbers: 3774400
- 3774401
- 3774402
- 3774406
- 3774411
- 3774412
- 3774413
- 3778527
- 3778528
- 3778529
- 3778530
- 3778531
- 3778532
- 3778533
- 3778534
- 3778535
- 3782488
- 3782489
- 3782490
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.
See all 28 products in this recall →Related recalls
Same manufacturer · Smiths Medical ASD Inc.
See all →- SevereCADD Solis VIP Ambulatory Infusion Pump Thermal Damage Recall
FDA (Devices) · 2025-05-14
- SevereCADD-Solis Infusion Pump Thermal Damage Risk Recall
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis Ambulatory Infusion Pump False Alarm Malfunction
FDA (Devices) · 2025-05-14
- CriticalCADD Solis HSPCA Pump wireless connection alarm interruption recall
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis VIP Ambulatory Infusion Pump False Occlusion Alarm Recall
FDA (Devices) · 2025-05-14
Same hazard · device defect
See all →- SevereBard Access Systems Recalls Power-Trialysis Dialysis Catheters
FDA (Devices) · 2026-09-23
- SevereBoston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation
FDA (Devices) · 2026-08-26
- HighMicrovention Recalls Bobby Balloon Guide Catheters Due to Pinhole Defects
FDA (Devices) · 2026-08-19
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722
FDA (Devices) · 2026-08-05
- SevereAbiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
FDA (Devices) · 2026-07-22
Similar recalls
- ModerateSmiths Medical Recalls Bivona Tracheostomy Tubes Due to Packaging Error
FDA (Devices) · 2021-01-06
- HighSmiths Medical Recalls Bivona Cuffless FlexTend Tracheostomy Tubes Due to Packaging Error
FDA (Devices) · 2021-03-03
- ModerateSmiths Medical Recalls Pediatric Tracheostomy Tubes Due to Packaging Error
FDA (Devices) · 2020-07-08
- ModerateSmiths Medical Recalls Mislabelled Pediatric Tracheostomy Tubes
FDA (Devices) · 2017-03-22
- SevereSmiths Medical Tracheostomy Tubes Recalled Due to Pilot Balloon Disconnection Risk
FDA (Devices) · 2024-09-18
- HighBivona Uncuffed Endotracheal Tubes Recalled for Compromised Sterile Barrier
FDA (Devices) · 2021-11-03