IV Sets with drip chambers recallZ-3160-2026 · ICU Medical, Inc. · initiated May 12, 2026
Class II Open, Classified All recalls posted in September 2026
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ICU Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Process control
What the company is doing
On 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 [email protected] 3) Continue using products as intended and per facility protocol. 4) Report any product quality concerns to ICU Medical Complaint Management. Firm contacts: [email protected] 1-866-261-8806. [email protected] 1-800-258-5361
Recall details
- Recall number
- Z-3160-2026
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- May 12, 2026
- Posted by the FDA
- Sep 11, 2026
- Recalling firm
- ICU Medical, Inc.
- Quantity
- 100,712,657
- Product code
- FPA
- FDA submissions
- K081361, K100576, K142367, K142622, K974589
- 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.
Product description
IV Sets with drip chambers
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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
Devices named in this recall
38 devices in the FDA device registry whose identifier appears in the recall's code information.
- Lifeshield 1423028ICU Medical, Inc. · Set, administration, intravascular1 recall48 reports
- Lifeshield 1266128ICU Medical, Inc. · Set, administration, intravascular1 recall5 reports
- ICU Medical Z3626Icu Medical, Inc. · Stopcock, i.V. Set1 recall2 reports
- Lifeshield 2066928ICU Medical, Inc. · Set, administration, intravascular1 recall1 report
- Primary Sets B917801ICU Medical, Inc. · Set, administration, intravascular1 recall1 report
- ICU Medical CH3025Icu Medical, Inc. · Set, administration, intravascular1 recall0 reports
- ICU Medical CH3035Icu Medical, Inc. · Set, administration, intravascular1 recall0 reports
- ICU Medical Z0180Icu Medical, Inc. · Stopcock, i.V. Set1 recall0 reports
- ICU Medical Z0882Icu Medical, Inc. · Stopcock, i.V. Set1 recall0 reports
- ICU Medical Z1095Icu Medical, Inc. · Stopcock, i.V. Set1 recall0 reports
- ICU Medical Z1304Icu Medical, Inc. · Set, administration, intravascular1 recall0 reports
- ICU Medical Z1426Icu Medical, Inc. · Stopcock, i.V. Set1 recall0 reports
- ICU Medical Z1803Icu Medical, Inc. · Set, administration, intravascular1 recall0 reports
- ICU Medical Z1867Icu Medical, Inc. · Set, administration, intravascular1 recall0 reports
- ICU Medical Z2084Icu Medical, Inc. · Set, administration, intravascular1 recall0 reports
- ICU Medical Z2850Icu Medical, Inc. · Set, administration, intravascular1 recall0 reports
- ICU Medical Z3000Icu Medical, Inc. · Stopcock, i.V. Set1 recall0 reports
- ICU Medical Z3319Icu Medical, Inc. · Stopcock, i.V. Set1 recall0 reports
- ICU Medical Z3491Icu Medical, Inc. · Stopcock, i.V. Set1 recall0 reports
- ICU Medical Z3672Icu Medical, Inc. · Stopcock, i.V. Set1 recall0 reports
- ICU Medical Z7107Icu Medical, Inc. · Set, administration, intravascular1 recall0 reports
- ICU Medical SC125Icu Medical, Inc. · Set, administration, intravascular1 recall0 reports
- ICU Medical B30201Icu Medical, Inc. · Set, administration, intravascular1 recall0 reports
- ICU Medical Z3750Icu Medical, Inc. · Stopcock, i.V. Set1 recall0 reports
- ICU Medical Z3822Icu Medical, Inc. · Stopcock, i.V. Set1 recall0 reports
- ICU Medical Z3874Icu Medical, Inc. · Stopcock, i.V. Set1 recall0 reports
- ICU Medical Z7180Icu Medical, Inc. · Stopcock, i.V. Set1 recall0 reports
- ICU Medical B33844Icu Medical, Inc. · Set, administration, intravascular1 recall0 reports
- ICU Medical CH3639Icu Medical, Inc. · Set, administration, intravascular1 recall0 reports
- ICU Medical B9371-04Icu Medical, Inc. · Set, administration, intravascular1 recall0 reports
- Lifeshield 1266328ICU Medical, Inc. · Set, administration, intravascular1 recall0 reports
- Lifeshield 2067128ICU Medical, Inc. · Set, administration, intravascular1 recall0 reports
- Lifeshield 1266528ICU Medical, Inc. · Set, administration, intravascular1 recall0 reports
- Lifeshield 1266928ICU Medical, Inc. · Set, administration, intravascular1 recall0 reports
- Lifeshield 1272828ICU Medical, Inc. · Set, administration, intravascular1 recall0 reports
- Lifeshield 1423528ICU Medical, Inc. · Set, administration, intravascular1 recall0 reports
- Lifeshield 1422728ICU Medical, Inc. · Set, administration, intravascular1 recall0 reports
- Lifeshield 1422228ICU Medical, Inc. · Set, administration, intravascular1 recall0 reports
Product lines
Other devices under the same FDA submission
56 devices cleared under K081361, K100576, K142367, K142622, K974589 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- ICU Medical MC33213Icu Medical, Inc. · Set, administration, intravascular54 reports
- ICU Medical CH3322Icu Medical, Inc. · Set, administration, intravascular1 recall0 reports
- ICU Medical CL4001Icu Medical, Inc. · Set, administration, intravascular1 recall0 reports
- ICU Medical SC160Icu Medical, Inc. · Set, administration, intravascular1 recall0 reports
- ICU Medical CH3731Icu Medical, Inc. · Set, administration, intravascular1 recall0 reports
- ICU Medical MC33038Icu Medical, Inc. · Set, administration, intravascular31 reports
- ICU Medical MC33150Icu Medical, Inc. · Set, administration, intravascular29 reports
- ICU Medical CH3581Icu Medical, Inc. · Set, administration, intravascular16 reports
- ICU Medical MC33122Icu Medical, Inc. · Set, administration, intravascular13 reports
- ICU Medical CH4000Icu Medical, Inc. · Set, administration, intravascular11 reports
- ICU Medical 12514-01Icu Medical, Inc. · Set, administration, intravascular11 reports
- ICU Medical A1129Icu Medical, Inc. · Set, administration, intravascular1 death9 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 99058).
- Z-3156-2026 · Open, ClassifiedPlum administration sets
- Z-3157-2026 · Open, ClassifiedIV Non-Dedicated Gravity Administration Sets with drip chambers
- Z-3158-2026 · Open, ClassifiedOncology sets with drip chambers
- Z-3159-2026 · Open, ClassifiedOncology sets with drip chambers
- Z-3161-2026 · Open, ClassifiedIV Sets with drip chambers
- Z-3162-2026 · Open, ClassifiedIV Sets with drip chambers
- Z-3163-2026 · Open, ClassifiedIV Sets with drip chambers
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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