The Recall Desk
HighFDA (Devices)·Z-0371-2023·Announced 2022-12-14

2.5 mm LifePort Endotracheal Tube Adapters Deformation Risk

Bunnell's 2.5 mm LifePort Endotracheal Tube Adapters may deform due to improper packaging, potentially affecting ventilator performance. The defect may lead to hypercarbia, hypoxia, and gas trapping.

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 an FDA Class II recall of respiratory equipment where improper packaging may cause device deformation, affecting ventilator performance and potentially leading to serious complications such as hypoxia and hypercarbia. However, no illnesses or injuries have been reported, placing this at the high-risk threshold per the severity rubric.

Plain-English summary

Bunnell, Inc. is recalling 2.5 mm LifePort Endotracheal Tube Adapters sold as 10-packs (Catalog 9025, Lot 22042320) and as part of Patient Circuit Kits (Catalog 938, Lots 22052381, 22052407, 22062431, 22062458, 22062478). A total of 1606 affected assemblies were distributed nationwide across the United States and Canada.

Some adapters were packaged improperly and may deform at the tip. This deformation may impair the ability to pass a suction catheter or affect normal ventilator performance.

Impaired ventilator performance may lead to hypercarbia (elevated carbon dioxide), hypoxia (low oxygen), and gas trapping—all serious respiratory complications. Affected customers should stop using these adapters and contact Bunnell, Inc. for replacement or guidance.

The recalled product

Product
2.5 mm LifePort Endotracheal Tube Adapters 10-pack, Catalog: 9025; and 2.5 mm LifePort Endotracheal Tube Adaptors inside Patient Circuit Kits, Catalog: 938
Manufacturer
Bunnell, Inc.
Hazard
  • device-deformation
  • ventilator-malfunction
  • hypoxia
  • hypercarbia
  • gas-trapping

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 (9)

  • Catalog/UDI/Lot: 9025/10616120000034/22042320
  • and 2.5 mm LifePort Endotracheal Tube Adaptors
  • Lot: 22042320
  • inside 938/10616120000089
  • 00616120000082/22052381
  • 22052407
  • 22062431
  • 22062458
  • 22062478

Distribution

Distributed nationwide across the United States.