Merit Medical recalls basixSKY Inflation Device REF SKY1802 due to potential small hole in sterile barrier causing infection risk. Affected units have specific lot 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 basixSKY Inflation Devices with serial number SKY1802 that may have a small hole in the sterile barrier. This could expose users to pathogens or pyrogens, leading to infection. Affected devices have specific lot numbers and expiration dates.
The inflation device may have a small hole in the sterile barrier, which could allow pathogens or pyrogens to enter the device. Using the device with this hole might lead to infection or other health issues.
Users of basixSKY Inflation Devices with the specific serial number SKY1802 are affected. Patients using these devices for medical purposes are at risk of infection if the device has a small hole in the sterile barrier.
Check for the serial number SKY1802 on the device. Affected units have specific lot numbers and expiration dates: H2925228 (11/30/2026) and H2934728 (11/30/2026).
Look for the serial number SKY1802 on the device to confirm if it is affected.
The recalled device is the basixSKY Inflation Device with serial number SKY1802.
Using the affected device may result in exposure to pathogens or pyrogens, which could lead to infection.
Check for the serial number SKY1802 on the device. Affected units have specific lot numbers and expiration dates: H2925228 (11/30/2026) and H2934728 (11/30/2026).
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0071-2025 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-0071-2025 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.
