CLASS II ONGOING Device recall · Reported 23 Sep 2026 · FDA Enforcement Report

Plum administration sets recalled by ICU Medical

ICU Medical is recalling Plum administration sets, distributed nationwide in the US. The recall was initiated on 12 May 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll 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

Quantity recalled163,500,199

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3156-2026
FDA event ID: 99058
Recalling firm: ICU Medical, San Clemente, CA
Classification: Class II
Status: Ongoing
Recall initiated: 12 May 2026
FDA classified: 11 Sep 2026
Reported: 23 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Particulate Matter
Device type: Infusion Pumps

Timeline

12 May 2026	Recall initiated by company
11 Sep 2026	Classified by FDA	+122 days
23 Sep 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

Plum administration sets

Where it was distributed

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.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 29 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

7 other products · FDA event 99058

This product is part of a recall event; the main page for the event is Oncology sets with drip chambers recalled by ICU Medical.

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026	CLASS II	Oncology sets with drip chambers recalled by ICU Medical	ICU Medical	Foreign Material	Nationwide
23 Sep 2026	CLASS II	Oncology sets with drip chambers recalled by ICU Medical	ICU Medical	Foreign Material	Nationwide
23 Sep 2026	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
23 Sep 2026	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
23 Sep 2026	CLASS II	IV Non-Dedicated Gravity Administration Sets with drip chambers recalled	ICU Medical	Foreign Material	Nationwide
23 Sep 2026	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
23 Sep 2026	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide

More recalls from ICU Medical

All 663

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	CADD Yellow Medication Cassette Reservoir with NRFit connector US recalled	ICU Medical	Packaging Defects	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
23 Sep 2026Device	CLASS II	IV Non-Dedicated Gravity Administration Sets with drip chambers recalled	ICU Medical	Foreign Material	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide

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23 Sep 2026Device	CLASS II	IV Non-Dedicated Gravity Administration Sets with drip chambers recalled	ICU Medical	Foreign Material	Nationwide
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