The Recall Desk
HighFDA (Devices)·Z-0068-2025·Announced 2024-10-23

BlueFIRE Inflation Device Recalled for Sterile Barrier Defect Risk

BlueFIRE Inflation Devices may have a small hole in the sterile barrier, potentially exposing patients to pathogens that could cause infection. Contact your healthcare provider if you received this device.

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 involving a sterile barrier defect that creates potential exposure to pathogens and pyrogens, which could cause infection. However, no illnesses or injuries have been reported as of the recall announcement, making this a high-risk product with theoretical rather than realized harm.

Plain-English summary

Merit Medical Systems has recalled the BlueFIRE Inflation Device, Model REF: IN10140. The affected devices may contain a small hole in the sterile barrier, which could expose patients to pathogens and pyrogens and potentially lead to infection.

The recall affects devices distributed worldwide, including throughout the United States and internationally to France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, and Japan. A total of 5 units are affected, identified by UDI-DI 00884450363607 and Lot H2934827 (Expiration: 4/30/2027).

No cases of infection or patient harm have been reported as of this recall announcement. Patients who have received this device should contact their healthcare provider immediately to discuss whether they have been affected and to determine appropriate next steps, which may include device replacement or clinical follow-up.

The recalled product

Product
BlueFIRE Inflation Device, REF: IN10140
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device
Hazard
Affected units
5

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 (1)

  • REF/UDI-DI/Lot(Expiration): IN10140/00884450363607/H2934827(4/30/2027)

Distribution

Distributed nationwide across the United States.

The notice also names 48 states specifically:

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.

See all 10 products in this recall →

Related recalls

Same manufacturer · Merit Medical Systems, Inc.

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Same hazard · sterile barrier defect

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