Plum administration sets recallZ-3156-2026 · ICU Medical, Inc. · initiated May 12, 2026
Open, Classified
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-3156-2026
- Status
- Open, Classified
- Initiated by the company
- May 12, 2026
- Posted by the FDA
- Sep 11, 2026
- Recalling firm
- ICU Medical, Inc.
- Quantity
- 163,500,199
- Product code
- FPA
- 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
Plum administration sets
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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
Devices named in this recall
14 devices in the FDA device registry whose identifier appears in the recall's code information.
- Plum 1468728ICU Medical, Inc. · Set, administration, intravascular1 recall2 deaths482 reports
- Plum 1425528ICU Medical, Inc. · Set, administration, intravascular1 recall164 reports
- Plum 1233912ICU Medical, Inc. · Set, administration, intravascular1 recall131 reports
- ICU Medical 15247-28Icu Medical, Inc. · Set, administration, intravascular1 recall13 reports
- ICU Medical 15339-28Icu Medical, Inc. · Set, administration, intravascular1 recall9 reports
- Lifeshield 1495188ICU Medical, Inc. · Set, administration, intravascular1 recall3 reports
- ICU Medical 15256-28Icu Medical, Inc. · Set, administration, intravascular1 recall1 report
- Plum 1425128ICU Medical, Inc. · Set, administration, intravascular1 recall1 report
- ICU Medical 15951-28Icu Medical, Inc. · Set, administration, intravascular1 recall0 reports
- Plum 1973201ICU Medical, Inc. · Set, administration, intravascular1 recall0 reports
- Plum 1427128ICU Medical, Inc. · Set, administration, intravascular1 recall0 reports
- Plum 1467928ICU Medical, Inc. · Set, administration, intravascular1 recall0 reports
- Plum 1495588ICU Medical, Inc. · Set, administration, intravascular1 recall0 reports
- Plum 1424328ICU Medical, Inc. · Set, administration, intravascular1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 99058).
- 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-3160-2026 · Open, ClassifiedIV 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 16, 2026. Text above is shown as published by the FDA.
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