ICU Medical, Inc. IV Sets with drip chambers recall: Intravascular administration tubing set drip chambers may have black specks
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.
The hazard: Sterility or particulate concern
Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.
What the notice says: 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.
Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.
Symptoms and when to call a doctor
Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.
This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.
Recall details
- Recall number
- Z-3163-2026
- Published
- September 23, 2026
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- ICU Medical, Inc.
- Product type
- Medical devices
- Units affected
- 56,553,672
- Distribution
- Nationwide
- Made in
- United States
- Lot / code info
- 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 1088770901451…
- UPC codes
- 10840619000025, 10840619000049, 10840619004481, 10840619004498, 10840619004627, 10840619099371, 10887709095981, 10887709093864, 10087219126704, 10840619060081, 10887709070124, 10887709123516, 10887709124643, 10887709090696, 10887709124414, 10887709066318, 10887709089812, 10887709090702, 10887709120171, 10887709120188
Products covered by this recall
IV Sets with drip chambers
Check your product
The notice names 22 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.
UPC / barcode
Read the twelve digits under the barcode on the package.
- 10840619000025
- 10840619000049
- 10840619004481
- 10840619004498
- 10840619004627
- 10840619099371
- 10887709095981
- 10887709093864
- 10087219126704
- 10840619060081
- 10887709070124
- 10887709123516
- 10887709124643
- 10887709090696
- 10887709124414
- 10887709066318
- 10887709089812
- 10887709090702
- 10887709120171
- 10887709120188
Model or item number
On the rating label, the box or the instruction sheet.
- before 7
- 2026. UDI-DI
Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Sterility
ICU Medical, Inc. — Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.
- Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
- Report any infection or reaction you think the product caused to FDA MedWatch.
- Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.
- Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.
What the company owes you
A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.
- The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
- Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
- Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
- Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.
Company contact: ICU Medical, Inc. — 951 Calle Amanecer, San Clemente, CA, 92673-6212
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was ICU Medical, Inc. medical devices 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. 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…
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: UPC 10840619000025, 10840619000049, 10840619004481; model number before 7, 2026. UDI-DI. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
Can I get my money back?
The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
Where was the recalled product sold?
It was distributed nationwide.
Related recalls
-
Class II · last month
ICU Medical, Inc. Oncology sets with drip chambers recall: Intravascular administration tubing set drip chambers may have black specks
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored…
-
Class II · last month
ICU Medical, Inc. Oncology sets with drip chambers recall: Intravascular administration tubing set drip chambers may have black specks
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored…
-
Class II · last month
ICU Medical, Inc. IV Sets with drip chambers recall: Intravascular administration tubing set drip chambers may have black specks
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored…
-
Class II · last month
ICU Medical, Inc. Plum administration sets recall: Intravascular administration tubing set drip chambers may have black specks
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored…
-
Class II · last month
ICU Medical, Inc. IV Sets with drip chambers recall: Intravascular administration tubing set drip chambers may have black specks
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored…
-
Class II · last month
ICU Medical, Inc. IV Non-Dedicated Gravity Administration Sets with drip chambers recall: Intravascular administration tubing set drip chambers may have black specks
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored…