Reported Jan 28, 2026 · Ongoing

Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H…

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 Inflation Device.basixCOMPAK.30 atm/bar.20
  • mL Reference Numbers
    • ENDO-AN2030/B
    • IN4130/CNK
    • IN4130/H
    • IN4130/JPH
    • IN4130/K
    • IN4130/KRK
    • IN4130/L
    • IN4130/T
    • IN4230/JPH
    • IN4230/K
    • IN4330/CNK
    • IN4330/K
    • IN4352/K
    • IN4430/K
    • IN4530/CNK
    • IN4530/K
    • IN4530/T
    • IN4802/K
    • IN4802/T
    • IN4852/K
    • IN4901/A
    • IN4902/A
    • IN4903/A
    • IN4904/A
    • IN4905/A
    • IN4906/A
    • IN4907/A
    • IN4908
    • IN4909
    • IN4910
    • IN4911/A
    • IN4912
    • IN4913/A
    • IN4914/A
    • IN4915
    • IN4916/A
    • IN4917/A
    • IN4918/A
    • IN4919/A
Lot codes and dates
  • Reference Number/UDI Number/Lot Number(s)

    2,395 of 2,395 codes

    • ENDO-AN2030/B
    • 00884450645161
    • I2559664
    • 00884450645161
    • I2617758
    • 00884450645161
    • I2622046
    • 00884450645161
    • I2657805
    • 00884450645161
    • I2937082
    • 00884450645161
    • I3056430
    • 00884450645161
    • I3085664
    • 00884450645161
    • I3118225
    • 00884450645161
    • I3251180
    • 00884450645161
    • I3282751
    • IN4130/CNK
    • 00884450636695
    • I2559550
    • 00884450636695
    • I2559551
    • 00884450636695
    • I2563338
    • 00884450636695
    • I2563339
    • 00884450636695
    • I2563340
    • 00884450636695
    • I2564655
    • 00884450636695
    • I2564665
    • 00884450636695
    • I2567481
    • 00884450636695
    • I2567482
    • 00884450636695
    • I2567483
    • 00884450636695
    • I2578099
    • 00884450636695
    • I2578100
    • 00884450636695
    • I2584021
    • 00884450636695
    • I2584024
    • 00884450636695
    • I2584025
    • 00884450636695
    • I2584026
    • 00884450636695
    • I2607299
    • 00884450636695
    • I2607301
    • 00884450636695
    • I2607302
Amount recalled
4,163,123 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.

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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, 4:17 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.