Reported Oct 23, 2024 · Ongoing

basixTOUCH Inflation Device, REF: IN8140/A

Merit Medical Systems, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Merit Medical Systems, Inc. · 1600 W Merit Pkwy · South Jordan, UT · 84095-2416

Is this the product you have?

  • basixTOUCH Inflation Device
  • REFIN8140/A
Lot codes and dates
  • REF/UDI-DI/Lot(Expiration)
    • IN8140/A/00884450627105/H2925218(4/22/2027)
    • H2929411(4/29/2027)
    • H2938003(4/30/2027)
    • H2972592(4/30/2027)
    • H2982505(12/31/2026)
Amount recalled
1952

This recall covers 16 products

The agency filed one notice per product. You are reading one of them; the other 15 are below.

3 more are in the archive.

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:33 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.