IntelliSystem Inflation Device (Merit Medical) – Sterile Barrier Breach (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
IntelliSystem Inflation Device, REF: IN1525/D
Brand
Merit Medical Systems, Inc.
Lot Codes / Batch Numbers
REF/UDI-DI/Lot(Expiration): IN1525/D/00884450298015/ H2918426(4/22/2027), H2934697(1/31/2027)
Products Sold
REF/UDI-DI/Lot(Expiration): IN1525/D/00884450298015/ H2918426(4/22/2027), H2934697(1/31/2027)
Merit Medical Systems, Inc. is recalling IntelliSystem Inflation Device, REF: IN1525/D due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 8/19/24, recall notices were emailed to customers asking them to do the following: 1) If affected devices are discovered, quarantine them, discontinue use and distribution, and return to the recalling firm. 2) Ensure that applicable personnel within your organization are made aware of this field action. 3) If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the customer response form. 4) Complete and return the customer response form via email to response@merit.com If you have any questions concerning this communication, please contact the firm's Sales Representatives or Customer Service via email at RESPONSE@merit.com or via phone at +1 800 356 3748, Hours: 6 am to 6 pm MST, Mon-Fri.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026