CLASS II ONGOING Device recall · Reported 23 Sep 2026 · FDA Enforcement Report

IV Sets with drip chambers recalled by ICU Medical

ICU Medical is recalling IV Sets with drip chambers, distributed nationwide in the US. The recall was initiated on 12 May 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll 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

Quantity recalled6,105,468

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3161-2026
FDA event ID: 99058
Recalling firm: ICU Medical, San Clemente, CA
Classification: Class II
Status: Ongoing
Recall initiated: 12 May 2026
FDA classified: 11 Sep 2026
Reported: 23 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Particulate Matter
Device type: Syringes & Needles

Timeline

12 May 2026	Recall initiated by company
11 Sep 2026	Classified by FDA	+122 days
23 Sep 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

IV Sets with drip chambers

Where it was distributed

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.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 29 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

7 other products · FDA event 99058

This product is part of a recall event; the main page for the event is Oncology sets with drip chambers recalled by ICU Medical.

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026	CLASS II	Oncology sets with drip chambers recalled by ICU Medical	ICU Medical	Foreign Material	Nationwide
23 Sep 2026	CLASS II	Oncology sets with drip chambers recalled by ICU Medical	ICU Medical	Foreign Material	Nationwide
23 Sep 2026	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
23 Sep 2026	CLASS II	Plum administration sets recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
23 Sep 2026	CLASS II	IV Non-Dedicated Gravity Administration Sets with drip chambers recalled	ICU Medical	Foreign Material	Nationwide
23 Sep 2026	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
23 Sep 2026	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide

More recalls from ICU Medical

All 663

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	CADD Yellow Medication Cassette Reservoir with NRFit connector US recalled	ICU Medical	Packaging Defects	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
23 Sep 2026Device	CLASS II	IV Non-Dedicated Gravity Administration Sets with drip chambers recalled	ICU Medical	Foreign Material	Nationwide
23 Sep 2026Device	CLASS II	Plum administration sets recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide

Other Syringes & Needles recalls

All 1,065

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
23 Sep 2026Device	CLASS II	Medrad¿ Stellant Flex Syringe Kit used recalled by Bayer Medical Care	Bayer Medical Care	Sterility	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
26 Aug 2026Device	CLASS I	BD Needle Kit for Powered Driver recalled by Bard Access Systems	Bard Access Systems	Other	32 states