Bivona Uncuffed Endotracheal Tubes Recalled for Compromised Sterile Barrier
Smiths Medical ASD Inc. is recalling 2,191 Bivona Uncuffed Wire Endotracheal Tubes due to inadequate pouch seals that compromise the sterile barrier. Affected devices have 325mm shaft lengths and were distributed nationwide and internationally.
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: This is a Class II FDA medical device recall for a compromised sterile barrier on a critical airway device. No illnesses or injuries have been reported, and the risk is theoretical. Per the rubric, this qualifies as High (Score 3): a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Smiths Medical ASD Inc. is recalling Bivona Uncuffed Wire Endotracheal Tubes due to a defect in the sterile barrier packaging. The recall affects SKU 15W080 (65 identified lot numbers), along with SKU 15W085, SKU 15W090, and SKU 15W095. In total, 2,191 devices are affected.
The defect involves inadequate sealing of the sterile pouch on products with a 325mm shaft length, resulting in a compromised sterile barrier. This defect may allow contamination or loss of sterility during storage or handling prior to use.
Affected devices were distributed to healthcare facilities nationwide across 21 U.S. states (Alabama, Arizona, California, Connecticut, Florida, Georgia, Illinois, Kentucky, Massachusetts, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington, and Hawaii) and internationally to Bermuda, Canada, Germany, Denmark, Great Britain, and Italy.
Healthcare providers should immediately verify inventory for devices from the affected lot numbers, cease use of any recalled units, and contact Smiths Medical ASD Inc. or the FDA for information on device return or replacement options.
The recalled product
- Product
- Bivona Uncuffed Wire Endotracheal Tubes,
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- seal-failure
- sterile-barrier-compromise
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)
- SKU 15W080 Lots #'s: 3221795
- 3221796
- 3226185
- 3250343
- 3263023
- 3272646
- 3301497
- 3301498
- 3312810
- 3312811
- 3315720
- 3315721
- 3338833
- 3346070
- 3361916
- 3370107
- 3379478
- 3433337
- 3437237
- 3442378
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- 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