Reported Sep 2, 2026 · Ongoing · Updated Sep 16, 2026

IV Sets with drip chambers

ICU Medical, 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: ICU Medical, Inc. · 951 Calle Amanecer · San Clemente, CA · 92673-6212

Is this the product you have?

  • IV Sets with drip chambers
Lot codes and dates
  • All products manufactured on or before 7/4/2026
  • UDI-DI
    • 10887709053783
    • 10887709053905
    • 10887709078267
    • 10887709054100
    • 10887709054230
    • 10887709054230
    • 10887709054414
    • 10887709054445
    • 10887709054476
    • 10887709054636
    • 10887709054711
    • 10887709054742
    • 10887709054803
    • 10887709054810
    • 10887709054827
    • 10887709054834
    • 10887709072050
    • 10887709051512
    • 10887709064192
    • 10887709065205
    • 10887709071060
    • 10887709071367
    • 10887709075655
    • 10887709076270
    • 10887709077802
    • 10887709078458
    • 10887709078489
    • 10887709078519
    • 10887709078700
    • 10887709078809
    • 10887709081465
    • 10887709095301
    • 10887709095318
    • 10887709098319
Amount recalled
1,721,800

Where it was sold

Why it was recalled

Product may have black specks which could result in a delay in therapy.

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 (Enforcement Report)

Read the FDA (weekly enforcement report) notice

Notice updated Sep 2, 2026 · Data as of Sep 19, 2:46 PM UTC

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