The Recall Desk
HighFDA (Devices)·Z-0178-2022·Announced 2021-11-03

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.
Category
Medical Device — Airway Management
Hazard
Affected units
2,191

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.

The notice also names 22 states specifically:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Related recalls

Same manufacturer · Smiths Medical ASD Inc.

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Same hazard · seal failure

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