The Recall Desk
HighFDA (Devices)·Z-0069-2025·Announced 2024-10-23

MONARCH Inflation Device Recalled Due to Sterile Barrier Defect Risk

Merit Medical Systems recalled 12,910 MONARCH Inflation Devices worldwide due to a potential hole in the sterile barrier. The defect could expose the device to pathogens and pyrogens, potentially leading to 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 is an FDA Class II recall of a medical device with a sterile barrier defect that could expose patients to pathogens and pyrogens. Although the hazard is theoretical (no illnesses reported in the source), a risk-of-harm medical device without reported injuries falls under the 'High' category per the rubric.

Plain-English summary

Merit Medical Systems, Inc. has recalled the MONARCH Inflation Device (model references IN2430/B, IN2530/B, and IN2130/B) because the devices may have a small hole in the sterile barrier.

The hole could allow exposure to pathogens and pyrogens during use, which could lead to infection. Approximately 12,910 units are affected by this recall.

The affected devices were distributed worldwide, including to healthcare facilities across the United States and in France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, and Japan. If you have one of these devices, contact your healthcare provider or Merit Medical Systems for further information.

The recalled product

Product
MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device
Hazard
  • sterile-barrier-breach
  • pathogen-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 (14)

  • H2925194(4/22/2027)
  • H2929405(4/29/2027)
  • H2934699(5/5/2027)
  • H2937986(5/12/2027)
  • H2943479(5/26/2027)
  • H2978085(6/3/2027)
  • H2982496(6/10/2027). IN2130/B/00884450298022/H2918427(4/22/2027)
  • H2925193(4/22/2027)
  • H2929404(4/29/2027)
  • H2934698(5/5/2027)
  • H2937984(5/12/2027)
  • H2943477(6/3/2027)
  • H2972585(5/26/2027)
  • H2982494(6/10/2027).

Distribution

Distributed nationwide across the United States.

Related recalls

Same category