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U.S. Department of Health and Human Services

Class 2 Device Recall IV Sets with drip chambers

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 Class 2 Device Recall IV Sets with drip chamberssee related information
Date Initiated by FirmMay 12, 2026
Date PostedSeptember 11, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3160-2026
Recall Event ID 99058
510(K)NumberK100576 K142367 K142622 K974589 K081361 
Product Classification Set, administration, intravascular - Product Code FPA
ProductIV Sets with drip chambers
Code Information 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
FEI Number 2025816
Recalling Firm/
Manufacturer		 ICU Medical, Inc.
951 Calle Amanecer
San Clemente CA 92673-6212
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionOn 5/12/2026, the firm posted a Information Regarding Reported Black Specks in Certain IV Tubing Set Drip Chambers from ICU Medical document on their website. On 5/18/2026, updated the notices were sent. On 7/28/2026, correction notices were sent to customers asking them to do the following: 1) Share this notification with all potential users of the device to ensure they are aware of this notification. If the devices are used or further distributed to another location, please ensure that this communication is delivered there. 2) Complete and return the attached Customer Response Form to MarketAction@mailac.custhelp.com 3) Continue using products as intended and per facility protocol. 4) Report any product quality concerns to ICU Medical Complaint Management. Firm contacts: GlobalComplaints@icumed.com 1-866-261-8806. customerservice@icumed.com 1-800-258-5361
Quantity in Commerce100,712,657
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FPA
510(K)s with Product Code = FPA
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