Class II U.S. Food and Drug Administration

ICU Medical, Inc. IV Sets with drip chambers recall: Intravascular administration tubing set drip chambers may have black specks

Recall published last month

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

This recall is about sterility assurance. It does not mean every unit is contaminated — it means the manufacturer cannot demonstrate that none of them is.

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-3161-2026
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
6,105,468
Distribution
Nationwide
Made in
United States
Lot / code info
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
UPC codes
10840619023307, 10840619023338, 10840619023369, 10840619036468, 10840619023963, 10840619041288, 10840619024007, 10840619024809, 10840619036796, 10840619068278, 10840619075993, 10840619083431, 10887709074726, 10887709085913, 10887709097176, 10887709098340, 10840619056480, 10840619054783, 10887709057019, 10887709086415

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.

  • 10840619023307
  • 10840619023338
  • 10840619023369
  • 10840619036468
  • 10840619023963
  • 10840619041288
  • 10840619024007
  • 10840619024809
  • 10840619036796
  • 10840619068278
  • 10840619075993
  • 10840619083431
  • 10887709074726
  • 10887709085913
  • 10887709097176
  • 10887709098340
  • 10840619056480
  • 10840619054783
  • 10887709057019
  • 10887709086415

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. — This recall is about sterility assurance. It does not mean every unit is contaminated — it means the manufacturer cannot demonstrate that none of them is.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.
  3. Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.
  4. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
  • If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.

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 10840619023307, 10840619023338, 10840619023369; 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?

Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.

Where was the recalled product sold?

It was distributed nationwide.

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