Lower risk Medical device recall · FDA · Published May 12, 2026

ICU Medical IV Sets with Drip Chambers May Have Black Specks

ICU Medical recalls IV sets with drip chambers made on or before July 4, 2026, due to potential black specks from plastic molding. Discard or return affected units to avoid risks.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-3161-2026Medical device ICU Medical ›

Lower-risk 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.

✎ GovInfoNow plain-language explainer

ICU Medical is recalling IV sets with drip chambers produced on or before July 4, 2026, because they may contain black specks from the plastic molding process. This could lead to discoloration or particulate matter in the fluid path, which might cause issues during medical use. Read more at govinfonow.com/recall/1135198-icu-medical-iv-sets-with-drip-chambers-may-have-black.

Source Summary by GovInfoNow · govinfonow.com/recall/1135198-icu-medical-iv-sets-with-drip-chambers-may-have-black · Updated October 4, 2026 · FDA enforcement record: FDA #Z-3161-2026

Cite this page

“ICU Medical IV Sets with Drip Chambers May Have Black Specks.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/1135198-icu-medical-iv-sets-with-drip-chambers-may-have-black. Based on FDA recall #Z-3161-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3161-2026%22&limit=1).

ICU Medical, Inc. recalled IV Sets with drip chambers manufactured on or before July 4, 2026, due to potential black specks in the tubing, according to the FDA. The Food and Drug Administration announced the Class II recall on May 12, 2026.

How to tell if you have it

Brand: ICU Medical
Product: IV Sets with drip chambers
Manufacture date: On or before 7/4/2026
Units affected: 6,105,468

The hazard

The intravascular administration tubing set drip chambers may contain 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.

Context

GovInfoNow's records show ICU Medical, Inc. has 60 other recalls on record since June 15, 2017. Recent similar recalls include an ICU Medical CADD Yellow Medication Cassette Reservoir Recall on August 20, 2026, and an ICU Medical Hotline Fluid Warming Set Recall on June 24, 2026. Other recent recalls of similar products include B Braun Medical Blood Set Recalls on October 29, 2025, and B Braun Medical IV Set Recalls on October 29, 2025.

How to tell if you have this one

Check for IV sets with drip chambers manufactured on or before July 4, 2026. The unique identifiers (UDI-DI) listed in the recall include numbers like 10840619023307 and 10887709074726.

Brand
ICU Medical
Category
Medical device

FDA recall event · 8 products

All 8 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
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.

Recall number	Product, codes & lots	Quantity
Z-3156-2026	Plum administration sets; 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	163,500,199
Z-3157-2026	IV Non-Dedicated Gravity Administration Sets with drip chambers; All products manufactured on or before 7/4/2026. UDI-DI: 10887709079363 10887709079370 10887709079417 10887709079431 10887709079448 10887709079455 10887709097473 10887709079493 10887709079509 10887709079547	2,450
Z-3158-2026	Oncology sets with drip chambers; All products manufactured on or before 7/4/2026. UDI-DI: 10840619054486, 10887709091914	107,800
Z-3159-2026	Oncology sets with drip chambers; All products manufactured on or before 7/4/2026. UDI-DI: 10887709076768, 10887709088105	28,550
Z-3160-2026	IV Sets with drip chambers; 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	100,712,657
Z-3161-2026	IV Sets with drip chambers; 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	6,105,468
Z-3162-2026	IV Sets with drip chambers; All products manufactured on or before 7/4/2026. UDI-DI: 20887787005831	86,113
Z-3163-2026	IV Sets with drip chambers; All products manufactured on or before 7/4/2026. UDI-DI:10840619000025 10840619000049 10840619004481 10840619004498 10840619004627 10840619099371 10887709095981 10887709093864 10087219126704 10840619060081 10887709070124 10887709123516 10887709124643 10887709090696 10887709124414 10887709066318 10887709089812 10887709090702 10887709120171 10887709120188 10887709122892 10887709122441 10887709123905 10887709124537 10887709126739 10887709095240 10887709095707 10887709124018 10887709085432 10887709086002 10887709088495 10887709088501 10887709088518 10887709089393 10887709089904 10887709091754 10887709091990 10887709095271 10887709121147 10887709128221 10887709003610 10887709003627 10887709003634 10887709003672 10887709003696 10887709003733 10887709003740 10887709003757 10887709003764 10887709051550 10887709050409 10887709003894 10887709003924 10887709003931 10887709003986 10887709003993 10887709084060 10887709004020 10887709004037 10887709055404 10887709004075 10887709004082 10887709074016 10887709004099 10887709004129 10887709004167 10887709004358 10887709004365 10887709004389 10887709004518 10887709004525 10887709004549 10887709004563 10887709004570 10887709004792 10887709004808 10887709004914 10887709055442 10887709055527 10887709055657 10887709068138 10887709064840 10887709004969 10887709004976 10840619045569 10887709004990 10887709005010 10840619045576 10840619045583 10887709005041 10887709005072 10887709005089 10887709005102 10887709005188 10887709005201 10887709005249 10887709081946 10887709093147 10887709094212 10887709099828 10887709005287 10887709005294 10887709005300 10887709005317 10887709005331 10887709005355 10887709005362 10887709005379 10887709005386 10887709005416 10887709005478 10887709005485 10887709005522 10887709005577 10887709005584 10887709005621 10887709005638 10887709005669 10887709005690 10887709005720 10887709007038 10887709007854 10887709055879 10887709078854 10887709080529 10887709080758 10887709081212 10887709081533 10887709081540 10887709081595 10887709082202 10887709082516 10887709082578 10887709083902 10887709084015 10887709085043 10887709085968 10887709085975 10887709085982 10887709089645 10887709090276 10887709092881 10887709092898 10887709095080 10887709095073 10887709124490 10887709121437 10887709121420 10887709121871 10887709122250 10887709122489 10887709126869 10887709008615 10887709008639 10887709009391 10887709009490 10887709009513 10887709009520 10887709009544 10887709009599 10887709009605 10887709009612 10887709009629 10887709009643 10887709009650 10887709009728 10887709009735 10887709009766 10887709009858 10887709009957 10887709063300 10887709068077 10887709068374 10887709069838 10887709010144 10887709010250 10887709010298 10887709010359 10887709010373 10887709010380 10887709010403 10887709010427 10887709010434 10887709010502 10840619045774 10887709010526 10887709010564 10887709010571 10887709010588 10887709010618 10887709010625 10887709010632 10887709010649 10887709010670 10887709056036 10887709010779 10887709010786 10887709010793 10887709010939 10887709011691 10887709011769 10887709012124 10887709012155 10887709012247 10887709012308 10887709012490 10887709012520 10887709012537 10887709051703 10887709056371 10887709056524 10887709062365 10887709065663 10887709068060 10887709068398 10887709068343 10887709069616 10887709069852 10887709069869 10887709069944 10887709071510 10887709072753 10887709072043 10887709071916 10887709077055 10887709076799 10887709076751 10887709076980 10887709078380 10887709012865 10887709013114 10887709013138 10887709013145 10887709013251 10887709013343 10840619045873 10887709013367 10887709013404 10887709013480 10887709013596 10887709013626 10887709013640 10887709013657 10887709062556 10887709013664 10887709013909 10887709013961 10887709014036 10840619045897 10887709014111 10887709014128 10887709014166 10887709014197 10887709014234 10887709014241 10887709014258 10887709071459 10887709014272 10887709014302 10887709014333 10887709014340 10887709014401 10887709014517 10887709014654 10887709014661 10887709014722 10887709014760 10887709014791 10887709014838 10887709014845 10887709014852 10887709014890 10887709015064 10887709015095 10840619045941 10887709015156 10887709015217 10887709015217 10887709015231 10887709015279 10887709015293 10887709015361 10887709015378 10887709015385 10887709015514 10887709015545 10887709015552 10887709015637 10887709015644 10887709015651 10887709015668 10887709015675 10887709015699 10887709015736 10887709015828 10887709056555 10887709063102 10887709071824 10887709015873 10887709015880 10887709015897 10887709015910 10887709015927 10887709015941 10887709015965 10887709015989 10887709016047 10887709016054 10887709016061 10887709016092 10887709016122 10887709016139 10887709016153 10887709016184 10887709016191 10887709016207 10887709016221 10887709016238 10887709016245 10840619045958 10840619045965 10887709016344 10887709016368 10887709016382 10887709016429 10840619045972 10887709016474 10887709016474 10887709016498 10887709016559 10887709016566 10887709016610 10887709016658 10887709016665 10887709016696 10887709016702 10887709016719 10887709016764 10840619046016 10887709016788 10887709016801 10887709016818 10887709016849 10887709016856 10887709016863 10887709016870 10887709016894 10887709016924 10887709016931 10887709017006 10887709017013 10887709017051 10887709017143 10887709017198 10887709017204 10887709017211 10887709017235 10887709017259 10887709017273 10887709017280 10887709017303 10887709017327 10887709017334 10887709017341 10887709017389 10887709017396 10887709017426 10887709017464 10887709017495 10887709017532 10887709017549 10887709017556 10887709017624 10887709017709 10887709017853 10887709017907 10887709017914 10887709017938 10887709017990 10887709018003 10887709018089 10887709018119 10887709018157 10887709018188 10887709018195 10887709018249 10887709018317 10887709018362 10887709018416 10887709018423 10887709018430 10887709018461 10887709018478 10887709018621 10887709018638 10887709018690 10887709018713 10887709018744 10887709018775 10887709018843 10887709018874 10887709018881 10887709018904 10887709018935 10887709018973 10887709018997 10887709019048 10887709019062 10887709019086 10887709019154 10887709019161 10887709019185 10887709019192 10887709019215 10887709019260 10887709019284 10887709019321 10887709019338 10887709019475 10887709019482 10887709019512 10887709019567 10887709019574 10887709019710 10887709056647 10887709056654 10887709056685 10887709056715 10887709056821 10887709062839 10887709064284 10887709067797 10887709068589 10887709068794 10887709019796 10887709075327 10887709076584 10887709076843 10887709078779 10887709083179 10887709063652 10887709019833 10887709019871 10840619024014 10840619034372 10840619034471 10887709084572 10887709084589 10887709087511 10887709088136 10887709088716 10887709091648 10887709097022 10887709124001 10887709039282 10887709039374 10887709078199 10887709079684 10840619090811 10842472100720 10887709040196 10887709071558 10887709074696 10887709074702 10887709076119 10887709079134 10887709091495 10887709096667 10887709040301 10887709040318 10887709040325 10887709040356 10887709040448 10887709040462 10887709040752 10887709040820 10887709058313 10887709058344 10887709058351 10887709052045 10840619034969 10887709041353 10887709041391 10887709041414 10887709041421 10887709041445 10887709041490 10887709041599 10887709041988 10887709020143 10887709020402 10887709020464 10887709020556 10887709020679 10887709020952 10887709021003 10887709021010 10887709021126 10887709021270 10887709021317 10887709021768 10887709021799 10887709023144 10887709023205 10887709023472 10887709023649 10887709023731 10887709023748 10887709024059 10887709024264 10887709024660 10887709024769 10887709024844 10887709025216 10887709025582 10887709025643 10887709026145 10887709026275 10887709026480 10887709026992 10887709027005 10887709027166 10887709027838 10887709027876 10887709027951 10887709028026 10887709028071 10887709028125 10887709028132 10887709028330 10887709028446 10887709028712 10887709028729 10887709029443 10887709029498 10887709029818 10887709030029 10887709030234 10887709030326 10887709030333 10887709030470 10887709030678 10887709031590 10887709032795 10887709033365 10887709033617 10887709033686 10887709034386 10887709034478 10887709035185 10887709058658 10887709059631 10887709080895 10887709087641 10840619000056 10840619004429 10840619004528 10840619029798 10840619099494 10840619019294 10840619036574 10840619056084 10840619090637 10840619093690 10840619077393 10840619035027 10840619028692 10840619056268 10840619086104 10840619094901 10840619003972 10840619004139 10840619004153 10840619004221 10840619004344 10840619029637 10840619029644 10840619056459 10840619004542 10840619004566 10840619004603 10840619004696 10840619004726 10840619004894 10840619004986 10840619005334 10840619005341 10840619005372 10840619005389 10840619029798 10840619036055 10840619040700 10887709099057 10887709124858 10887709124865 10840619005679 10887709093345 1088770900000 10840619099838 10840619097094 10840619097735 10887709094601 10840619090477 10887709093604 10840619097902 10887709098708 10887709099217 10887709099224 10887709122052 10887709123370 10887709123387 10840619076464 10840619082236 10840619082243 10840619076426 10840619076433 10840619094307 10840619095823 10887709095417 10887709095769 10840619007673 10840619007697 10840619054493 10840619008021 10840619008267 10840619008304 10840619008489 10840619008519 10840619008700 10840619011694 10840619013124 10840619013667 10840619014558 10840619015111 10840619015296 10840619015340 10840619017511 10840619019287 10840619019294 10840619019300 10840619019416 10840619020160 10840619031890 10840619032682 10840619033061 10840619033306 10840619033313 10840619033320 10840619036574 10840619043145 10840619056084 10840619062832 10840619056091 10840619066564 10840619065840 10840619066342 10840619069480 10840619075528 10840619037120 10840619083066 10840619090620 10840619091108 10840619093706 10840619096646 10887709122434 10887709124087 10887709124230 10840619091573 10887709124803 10887709124810 10887709125022 10840619092952 10840619095717 10887709098449 10887709098869 10887709124827 10887709125039 10840619083462 10840619066649 10840619082281 10840619087972 10840619087989 10840619087965 10840619098657 10840619098640 10840619095540 10887709003658 10887709050409 10887709003979 10887709004174 10887709004624 10887709055510 10887709063218 10887709064598 10887709067476 10887709005133 10887709005140 10887709066998 10887709076461 10887709077239 10887709086330 10887709093970 10887709005263 10887709123363 10887709005393 10887709005508 10887709005614 10887709087115 10887709096063 10887709008639 10887709011837 10887709012544 10887709012575 10887709065021 10887709081847 10887709081908 10887709013336 10887709013572 10887709013800 10887709014012 10887709014418 10887709014586 10887709014739 10887709014746 10887709036410 10887709036434 10887709036502 10887709036533 10887709036632 10887709036731 10887709036786 10887709036816 10887709037073 10887709057491 10887709057521 10887709096834 10887709084558 10887709084510 10887709094229 10887709123035 10887709126319 10887709051864 10887709057651 10840619086029 10842472100713 10840619095816 10840619097162 10840619056695 10887709125633	56,553,672

Based on the official FDA remedy

What to do — step by step

Check Product Date
Verify the manufacturing date of the IV set drip chamber, which should be on or before July 4, 2026.
Contact Manufacturer
Reach out to ICU Medical directly for assistance with returning or discarding affected units.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 50 states.

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 4 months after the firm started it.

May 12, 2026Firm started the recall
Sep 11, 2026FDA classified it Class II
Sep 23, 2026Published in FDA’s Enforcement Report
Sep 29, 2026Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/1135198-icu-medical-iv-sets-with-drip-chambers-may-have-black">ICU Medical IV Sets with Drip Chambers May Have Black Specks (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-3161-2026 (May 12, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3161-2026 to see it in context.
Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.