Smiths Medical Tracheotomy Tube Kits Recalled for Pilot Balloon Disconnection
Smiths Medical is recalling approximately 12,234 BLUselect, BLUgriggs, and BLUperc tracheotomy tube kits due to a manufacturing defect that may cause the pilot balloon to disconnect from the inflation line.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device recall. Per the severity rubric, FDA Class I recalls never score below 4. The manufacturing defect in tracheostomy tube equipment poses a serious potential risk to patient airway management.
Plain-English summary
Smiths Medical ASD Inc. is recalling multiple models of BLUselect, BLUgriggs, and BLUperc percutaneous dilation procedural trays and kits with tracheotomy tubes. Approximately 12,234 units have been distributed worldwide across 17 different product configurations and multiple lot numbers.
The recall is due to a manufacturing defect that may cause disconnection of the pilot balloon from the tracheostomy inflation line. The affected products are identified by item number and specific lot numbers.
Healthcare providers using affected products should stop use immediately and contact Smiths Medical for replacements. Patients who may be using affected units should consult their healthcare provider. The FDA has classified this as a Class I recall, its highest severity category for medical devices.
The recalled product
- Product
- smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy tubes, labeled as follows: 1) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 8.0mm BLUselect trach tube (drugs, US ONLY), Item Number 101/540/080; 2) BLUgriggs
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- equipment-disconnection
- manufacturing-defect
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)
- 101/540/080
- Lot Number 3943992
- Lot Number 4258998
- 101/540/090
- Lot Number 4309778
- 101/541/070
- Lot Number 3887542
- Lot Number 3913366
- Lot Number 4202486
- Lot Number 4350937
- 101/541/080
- Lot Number 3887517
- Lot Number 3910324
- Lot Number 3912758
- Lot Number 4170885
- Lot Number 4184037
- Lot Number 4310310
- Lot Number 4312324
- Lot Number 4332049
- Lot Number 4332050
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03