Merit Medical recalls DiamondTOUCH Digital Inflation Devices with potential small holes in sterile barriers, risking infection from pathogens. Affected units have specific serial numbers and expiration dates.
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 DiamondTOUCH Digital Inflation Devices that may have a small hole in the sterile barrier, which could expose users to pathogens and cause infection. This recall affects specific model numbers and serial numbers with expiration dates.
The inflation devices may have a small hole in the sterile barrier, allowing pathogens or pyrogens to enter the device. Using these devices could lead to infection if the hole is present, as the sterile barrier is meant to prevent contamination.
Users of DiamondTOUCH Digital Inflation Devices with specific model numbers and serial numbers are affected. Healthcare professionals and medical device users are most at risk due to potential infection exposure.
Check the device's reference number (IN9135/A or IN9152/A) and the serial number on the packaging. Affected units have specific expiration dates: 4/15/2027 for IN9135/A and 4/8/2027 for IN9152/A.
Look for the reference number (IN9135/A or IN9152/A) and the serial number on the device packaging.
The recalled models are DiamondTOUCH Digital Inflation Device with reference numbers IN9135/A and IN9152/A.
Check the reference number and serial number on the packaging. Affected units have specific expiration dates: 4/15/2027 for IN9135/A and 4/8/2027 for IN9152/A.
The recall record does not specify a remedy, so contact Merit Medical Systems for further instructions.
We’ve drafted a message you can send Merit Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0066-2025 — Merit Medical Systems Merit Medical Systems Hello, I own a Merit Medical Systems that is covered by recall Z-0066-2025 from Merit Medical Systems. 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.
