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

IV Sets with drip chambers recalled by ICU Medical

ICU Medical is recalling IV Sets with drip chambers, 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: 20887787005633 20887787005640 20887787005664 20887787005961 20887787005985 20887787005992 20887787006005 20887787006029 20887787006142 20887787006449 20887787006418 20887787006340 20887787006319 20887787006289 20887787006265 10887709102016 20887787006258 20887787005329 20887787005923 20887787005930 20887787005947 10887709004112 10887709055626 10887709083407 10887709083414 20887787009303 20887787009273 20887787009280 10887709120218 20887787009297 10840619024021 10840619024069 10840619024120 10840619064409 10887709085715 10887709051895 10887709040141 20887709120208 10887709020518 10887709020907 10887709022017 10887709022215 10887709022352 10887709022444 10887709022871 10887709022987 10887709023090 10887709023601 10887709024110 10887709024257 10887709024295 10887709024578 10887709024967 10887709026886 10887709028248 10887709028965 10887709028972 10887709030074 10887709031132 10887709031941 10887709032801 10887709033549 10887709034089 10887709034379 10887709034546 10887709034874 10887709058597 10887709059235 10887709059242 10887709044453 10887709059686 10887709035802 10887709035871 10887709065625 10887709065632 10887709101705 10887709101767 30887709100221 10887709101712 10887709101750 20887709100224 20887709100231 20887709100293 10840619099388 10887709101736 30887709100320 20887709100323 30887709100528 10887709101743 20887787009303

Quantity recalled100,712,657

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-3160-2026
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: Syringes & Needles

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

IV Sets with drip chambers

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: 20887787005633 20887787005640 20887787005664 20887787005961 20887787005985 20887787005992 20887787006005 20887787006029 20887787006142 20887787006449 20887787006418 20887787006340 20887787006319 20887787006289 20887787006265 10887709102016 20887787006258 20887787005329 20887787005923 20887787005930 20887787005947 10887709004112 10887709055626 10887709083407 10887709083414 20887787009303 20887787009273 20887787009280 10887709120218 20887787009297 10840619024021 10840619024069 10840619024120 10840619064409 10887709085715 10887709051895 10887709040141 20887709120208 10887709020518 10887709020907 10887709022017 10887709022215 10887709022352 10887709022444 10887709022871 10887709022987 10887709023090 10887709023601 10887709024110 10887709024257 10887709024295 10887709024578 10887709024967 10887709026886 10887709028248 10887709028965 10887709028972 10887709030074 10887709031132 10887709031941 10887709032801 10887709033549 10887709034089 10887709034379 10887709034546 10887709034874 10887709058597 10887709059235 10887709059242 10887709044453 10887709059686 10887709035802 10887709035871 10887709065625 10887709065632 10887709101705 10887709101767 30887709100221 10887709101712 10887709101750 20887709100224 20887709100231 20887709100293 10840619099388 10887709101736 30887709100320 20887709100323 30887709100528 10887709101743 20887787009303

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	Plum administration sets 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

Other Syringes & Needles recalls

All 1,065

Reported	Class	Recall	Company	Reason	Where
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	Medrad¿ Stellant Flex Syringe Kit used recalled by Bayer Medical Care	Bayer Medical Care	Sterility	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
26 Aug 2026Device	CLASS I	BD Needle Kit for Powered Driver recalled by Bard Access Systems	Bard Access Systems	Other	32 states