FDAClass II · Medical device · Recall Z-3156-2026 · Recalled September 23, 2026

Plum administration sets 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: Plum administration sets
Company / brand: ICU Medical
Lot / serial / date codes: All products manufactured on or before 7/4/2026. UDI-DI: 10887709101460 30887709100023 30887709100030 10887709101477 30887709100047 30887709100054 20887787005312 20887787005404 10887709101484 30887709100092 20887709100118 20887709100125 30887709100139 10887709101491 20887709100149 20887709100156 20887709100163 20887709100170 20887709100187 20887709100194 30887709100207 20887709100460 20887709100804 10887709101569 30887709100733 20887709100347 20887709100354 20887787006234 20887787006227 20887787006180 20887787006487 20887787006036 20887787005978 20887787005237 10887709100869 20887787005251 10887709101675 20887787005268 20887709101689 20887787003011 20887787005350 20887787008801 20887787005626 20887787005657 20887787003202 20887787003233 20887787005725 20887787008771 20887787003431 10887709100906 10887709101613 10887709100920 20887709100880 20887709101627 10887709102566 10887709101507 10887709101637 20887709101511 20887709101641 20887709101849 20887709101771 20887709101832 20887787005657 10887709102450 10887709102054 10887709102344 10887709102351 10887709102481 10887709102368 10887709101668 10887709101668 10887709101552 10887709102443 10887709102467 10887709102474
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

Plum administration sets

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: Plum administration sets recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-3156-2026
Brand: All ICU Medical recalls
Classification: Class II
Units affected: 163,500,199
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Plum administration sets 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: 10887709101460 30887709100023 30887709100030 10887709101477 30887709100047 30887709100054 20887787005312 20887787005404 10887709101484 30887709100092 20887709100118 20887709100125 30887709100139 10887709101491 20887709100149 20887709100156 20887709100163 20887709100170 20887709100187 20887709100194 30887709100207 20887709100460 20887709100804 10887709101569 30887709100733 20887709100347 20887709100354 20887787006234 20887787006227 20887787006180 20887787006487 20887787006036 20887787005978 20887787005237 10887709100869 20887787005251 10887709101675 20887787005268 20887709101689 20887787003011 20887787005350 20887787008801 20887787005626 20887787005657 20887787003202 20887787003233 20887787005725 20887787008771 20887787003431 10887709100906 10887709101613 10887709100920 20887709100880 20887709101627 10887709102566 10887709101507 10887709101637 20887709101511 20887709101641 20887709101849 20887709101771 20887709101832 20887787005657 10887709102450 10887709102054 10887709102344 10887709102351 10887709102481 10887709102368 10887709101668 10887709101668 10887709101552 10887709102443 10887709102467 10887709102474
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

Other medical device recalls from around the same time

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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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