The Recall Desk
HighFDA (Devices)·Z-0071-2025·Announced 2024-10-23

Merit Medical basixSKY Inflation Device Recalled for Sterile Barrier Defect

Merit Medical is recalling the basixSKY Inflation Device because a sterile barrier defect could expose users to harmful pathogens and bacteria, risking infection.

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 FDA Class II device recall involves a sterile barrier defect creating potential for patient harm through pathogen and pyrogen exposure, with no reported injuries or illnesses. It meets the High severity criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Merit Medical Systems, Inc., is recalling the basixSKY Inflation Device (REF: SKY1802) due to a manufacturing defect in the sterile barrier. The device may contain a small hole in the sterile packaging that compromises its sterile integrity.

This defect could allow contamination of the device. If an affected device is used, patients may be exposed to pathogens and pyrogens, which could lead to infection.

Approximately 70 devices have been distributed worldwide, including throughout the United States and internationally to France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, and Japan. The affected lot numbers are H2925228 and H2934728, both expiring 11/30/2026.

Healthcare facilities and providers should immediately cease use of affected devices. Patients who may have been exposed should contact their healthcare provider for monitoring. For additional information, contact Merit Medical Systems, Inc.

The recalled product

Product
basixSKY Inflation Device, REF: SKY1802
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Inflation Device
Hazard
  • sterile-barrier-defect
  • pathogen-exposure
  • pyrogen-exposure
  • infection-risk

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 (2)

  • REF/UDI-DI/Lot(Expiration): SKY1802/00884450822500/H2925228(11/30/2026)
  • H2934728(11/30/2026).

Distribution

Distributed nationwide across the United States.

Related recalls

Same category