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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Affected units
- 70
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
Part of a larger recall action
This product is one of 10 recalled by Merit Medical Systems, 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.
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