FDA Device recall Z-3162-2026
IV Sets with drip chambers
- FDA Device
- Class II
- ongoing
- Published 2026-09-23
On 2026-09-23 the FDA classified a Class II recall of IV Sets with drip chambers by Icu Medical, citing intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material wit….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3162-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-12 |
| Published | 2026-09-23 |
| Last updated | 2026-09-29 05:30 UTC |
| Company | Icu Medical |
| Distribution | US |
Product
IV Sets with drip chambers
Reason
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.
Identifiers
| code_info | All products manufactured on or before 7/4/2026. UDI-DI: 20887787005831 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-29 05:30 UTC. Current status: ongoing.
Other recalls by Icu Medical
- IV Sets with drip chambers
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FDA Device · Class II · 2026-09-23 · Icu Medical - CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product Codes: 21-7609-24 21-76…
FDA Device · Class II · 2026-09-23 · Icu Medical - Oncology sets with drip chambers
FDA Device · Class II · 2026-09-23 · Icu Medical - IV Non-Dedicated Gravity Administration Sets with drip chambers
FDA Device · Class II · 2026-09-23 · Icu Medical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3162-2026%22
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