Food, drugs, devices › ICU Medical, Inc.
Device recall: Plum administration sets
ICU Medical, Inc. (San Clemente, CA) initiated this device recall on 12 May 2026; FDA lists 8 product records under event 99058, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 572 device enforcement events initiated in 2026 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. ICU Medical, Inc. has 75 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
ICU Medical, Inc., San Clemente, CA.
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."
Distribution
"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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-3156-2026 | Plum administration sets | 163,500,199 | Class II | Ongoing | 23 Sep 2026 |
| Z-3157-2026 | IV Non-Dedicated Gravity Administration Sets with drip chambers | 2,450 | Class II | Ongoing | 23 Sep 2026 |
| Z-3158-2026 | Oncology sets with drip chambers | 107,800 | Class II | Ongoing | 23 Sep 2026 |
| Z-3159-2026 | Oncology sets with drip chambers | 28,550 | Class II | Ongoing | 23 Sep 2026 |
| Z-3160-2026 | IV Sets with drip chambers | 100,712,657 | Class II | Ongoing | 23 Sep 2026 |
| Z-3161-2026 | IV Sets with drip chambers | 6,105,468 | Class II | Ongoing | 23 Sep 2026 |
| Z-3162-2026 | IV Sets with drip chambers | 86,113 | Class II | Ongoing | 23 Sep 2026 |
| Z-3163-2026 | IV Sets with drip chambers | 56,553,672 | Class II | Ongoing | 23 Sep 2026 |
Context
Other enforcement events for ICU Medical, Inc.
All 75 events for ICU Medical, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.