Merit Medical recalls MONARCH Inflation Devices with specific model numbers and batch codes due to potential small holes in sterile barriers that could cause infection. Affected units may need replacement.
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
Merit Medical is recalling certain MONARCH Inflation Devices because they might have small holes in the sterile barrier, which could expose users to pathogens and cause infection. This recall affects specific model numbers and batch codes produced between 2022 and 2027.
The inflation devices may have a small hole in the sterile barrier, which could allow pathogens or pyrogens to enter the device. Using these devices might lead to infection if the hole is present.
Users of the MONARCH Inflation Device with the model numbers IN2430/B, IN2530/B, or IN2130/B are most at risk. These devices were sold with specific batch codes and expiration dates between April 2022 and June 2027.
Check the device's model number (IN2430/B, IN2530/B, or IN2130/B) and batch code on the packaging or device itself. Affected units have specific batch codes with expiration dates from April 2022 through June 2027.
Look for the model number (IN2430/B, IN2530/B, or IN2130/B) and batch code on the device or packaging.
Reach out to Merit Medical Systems, Inc. for instructions on replacement or return of affected devices.
The devices may have a small hole in the sterile barrier, which could lead to exposure to pathogens or pyrogens and cause infection.
Check the model number (IN2430/B, IN2530/B, or IN2130/B) and batch code on the device or packaging. Affected units have specific batch codes with expiration dates from April 2022 through June 2027.
Contact Merit Medical Systems, Inc. for instructions on replacement or return of the affected device.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0069-2025 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-0069-2025 from Merit Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
