Reported Jan 28, 2026 · Ongoing
Merit Medical , Custom Manifold Kit REF: K09-13203A
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?
- Merit Medical
- Custom Manifold Kit REFK09-13203A
- Lot codes and dates
- K09-13203AUDI: 00884450479964 /Lot:
H2671718H2681531H2758436H2792533H2796074H3046979H3052442H3147779H3246149H3254530H3297407
- K09-13203AUDI: 00884450479964 /Lot:
- Amount recalled
- 2192 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
Inflation device handle may detach from the syringe during procedure.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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