FDAClass II · Medical device · Recall Z-3161-2026 · Recalled September 23, 2026

IV 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 Sets with drip chambers
Company / brand: ICU Medical
Lot / serial / date codes: All products manufactured on or before 7/4/2026. UDI-DI: 10840619023307 10840619023338 10840619023369 10840619036468 10840619023963 10840619041288 10840619024007 10840619024809 10840619036796 10840619068278 10840619075993 10840619083431 10887709074726 10887709085913 10887709097176 10887709098340 10840619056480 10840619054783 10887709057019 10887709086415 10887709099958 10887709072920 10887709099590 10887709075181 10887709099965 10887709123042 10887709075051 10887709071404 10887709057026 10887709120010 10887709057033 10887709057040 10887709120027 10887709083322 10887709085098 10887709088808 10887709073798 10887709073804 10887709088860 10887709090641 10887709095530 10887709122861 10887709095776 10887709097466 10887709121284 10840619085046 10840619024076 10840619034037 10840619078048 10840619079427 10840619079434 10887709098333 10887709080055 10840619064928 10887709089126 10887709081410 10887709088686 10887709122748 10840619094994 10887709085869
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 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. The presence of discoloration and particulate matter in the fluid path has not been ruled out.

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 Sets with drip chambers recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-3161-2026
Brand: All ICU Medical recalls
Classification: Class II
Units affected: 6,105,468
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

IV 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: 10840619023307 10840619023338 10840619023369 10840619036468 10840619023963 10840619041288 10840619024007 10840619024809 10840619036796 10840619068278 10840619075993 10840619083431 10887709074726 10887709085913 10887709097176 10887709098340 10840619056480 10840619054783 10887709057019 10887709086415 10887709099958 10887709072920 10887709099590 10887709075181 10887709099965 10887709123042 10887709075051 10887709071404 10887709057026 10887709120010 10887709057033 10887709057040 10887709120027 10887709083322 10887709085098 10887709088808 10887709073798 10887709073804 10887709088860 10887709090641 10887709095530 10887709122861 10887709095776 10887709097466 10887709121284 10840619085046 10840619024076 10840619034037 10840619078048 10840619079427 10840619079434 10887709098333 10887709080055 10840619064928 10887709089126 10887709081410 10887709088686 10887709122748 10840619094994 10887709085869
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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Haylard UNIV IMAGING BIOPSY TRUCUSTOM recall — AVID Medical, Inc.FDA · September 23, 2026
Haylard BASIC BIOPSY TRAY recall — AVID Medical, Inc.FDA · September 23, 2026
Haylard CONTINUOUS NERVE BLOCK TRAY recall — AVID Medical, Inc.FDA · September 23, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
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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