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
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-3162-2026
- 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 AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Why was it 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.
Which lots are affected?
All products manufactured on or before 7/4/2026. UDI-DI: 20887787005831
Where was it sold?
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.
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 99058This 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 |
|---|---|---|---|---|---|
| CLASS II | Oncology sets with drip chambers recalled by ICU Medical | ICU Medical | Foreign Material | Nationwide | |
| CLASS II | Oncology sets with drip chambers recalled by ICU Medical | ICU Medical | Foreign Material | Nationwide | |
| CLASS II | IV Sets with drip chambers recalled by ICU Medical | ICU Medical | Particulate Matter | Nationwide | |
| CLASS II | Plum administration sets recalled by ICU Medical | ICU Medical | Particulate Matter | Nationwide | |
| CLASS II | IV Sets with drip chambers recalled by ICU Medical | ICU Medical | Particulate Matter | Nationwide | |
| CLASS II | IV Non-Dedicated Gravity Administration Sets with drip chambers recalled | ICU Medical | Foreign Material | Nationwide | |
| 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 |
|---|---|---|---|---|---|
| Device | CLASS II | CADD Yellow Medication Cassette Reservoir with NRFit connector US recalled | ICU Medical | Packaging Defects | Nationwide |
| Device | CLASS II | IV Sets with drip chambers recalled by ICU Medical | ICU Medical | Particulate Matter | Nationwide |
| Device | CLASS II | IV Non-Dedicated Gravity Administration Sets with drip chambers recalled | ICU Medical | Foreign Material | Nationwide |
| Device | CLASS II | IV Sets with drip chambers recalled by ICU Medical | ICU Medical | Particulate Matter | Nationwide |
| Device | 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 |
|---|---|---|---|---|---|
| Device | CLASS II | IV Sets with drip chambers recalled by ICU Medical | ICU Medical | Particulate Matter | Nationwide |
| Device | CLASS II | Medrad¿ Stellant Flex Syringe Kit used recalled by Bayer Medical Care | Bayer Medical Care | Sterility | Nationwide |
| Device | CLASS II | IV Sets with drip chambers recalled by ICU Medical | ICU Medical | Particulate Matter | Nationwide |
| Device | CLASS II | IV Sets with drip chambers recalled by ICU Medical | ICU Medical | Particulate Matter | Nationwide |
| Device | CLASS I | BD Needle Kit for Powered Driver recalled by Bard Access Systems | Bard Access Systems | Other | 32 states |