FDAClass II · Medical device · Recall Z-3157-2026 · Recalled September 23, 2026

IV Non-Dedicated Gravity Administration Sets with drip chambers recall — ICU Medical, Inc.

Agency report date: September 23, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: IV Non-Dedicated Gravity Administration Sets with drip chambers
Company / brand: ICU Medical
Lot / serial / date codes: All products manufactured on or before 7/4/2026. UDI-DI: 10887709079363 10887709079370 10887709079417 10887709079431 10887709079448 10887709079455 10887709097473 10887709079493 10887709079509 10887709079547
Distribution: Worldwide - US Nationwide distribution including in the states and territories of ND, TX, CT, KY, CO, AR, NC, NJ, VA, MD, OK, AK, IA, IN, KS, OR, CA, OH, WA, GA, AL, SC, MA, HI, FL, NH, NE, MN, MS, SD, MT, NY, DC, ID, WI, PA, AZ, MO, NV, TN, NM, WV, WY, IL, UT, MI, RI, VT, LA, DE, ME, VI, GU, PR and the countries of PK, PH, MY, HK, IN, DE, CR.

Agency product description and boundaries

IV Non-Dedicated Gravity Administration Sets with drip chambers

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall that does not enter the fluid path, which if seen by a healthcare provider may lead to replacement of product before use, which could result in a delay in therapy.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: IV Non-Dedicated Gravity Administration Sets with drip chambers recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-3157-2026
Brand: All ICU Medical recalls
Classification: Class II
Units affected: 2,450
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

IV Non-Dedicated Gravity Administration Sets with drip chambers recall status

Companies & origin

Recalling firm location: San Clemente, CA, United States
Firm address: 951 Calle Amanecer, N/A, 92673-6212

Identifying details (verbatim from the notice)

Product codes / lots: All products manufactured on or before 7/4/2026. UDI-DI: 10887709079363 10887709079370 10887709079417 10887709079431 10887709079448 10887709079455 10887709097473 10887709079493 10887709079509 10887709079547
Distribution: Worldwide - US Nationwide distribution including in the states and territories of ND, TX, CT, KY, CO, AR, NC, NJ, VA, MD, OK, AK, IA, IN, KS, OR, CA, OH, WA, GA, AL, SC, MA, HI, FL, NH, NE, MN, MS, SD, MT, NY, DC, ID, WI, PA, AZ, MO, NV, TN, NM, WV, WY, IL, UT, MI, RI, VT, LA, DE, ME, VI, GU, PR and the countries of PK, PH, MY, HK, IN, DE, CR.
Firm notified the public via: Press Release
FDA event ID: 99058
Recall initiated: May 12, 2026
FDA classified: September 11, 2026
FDA report date: September 23, 2026

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Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
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FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved October 22, 2026 at 6:00 PM UTC.

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