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

Oncology sets with drip chambers recalled by ICU Medical

ICU Medical is recalling Oncology 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: 10887709076768, 10887709088105

Quantity recalled28,550

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-3159-2026
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: Foreign Material
Device type: Other Medical Devices

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 that does not enter the fluid path, which if seen by a healthcare provider may lead to replacement of product before use, which could result in a delay in therapy.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Oncology 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: 10887709076768, 10887709088105

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

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	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 Sets with drip chambers 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	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide

Other Other Medical Devices recalls

All 13,817

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	Convenience kits Cataract Pack DYNJ59881A recalled by Medline Industries	Medline Industries	Sterility	Nationwide
23 Sep 2026Device	CLASS II	Percutaneous Insertion Kit (PIK), dilator set recalled	Maquet Cardiopulmonary	Sterility	Nationwide
23 Sep 2026Device	CLASS II	Blood Culture Collection Venipuncture Kit 20/Cs recalled	Medical Action Industries Inc. 306	Sterility	Nationwide
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	Aisys, Datex-Ohmeda anesthesia system recalled	Datex-Ohmeda	Device Malfunction	Nationwide