FDA Device recall Z-3160-2026
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-3160-2026 |
| 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: 20887787005633 20887787005640 20887787005664 20887787005961 20…All products manufactured on or before 7/4/2026. UDI-DI: 20887787005633 20887787005640 20887787005664 20887787005961 20887787005985 20887787005992 20887787006005 20887787006029 20887787006142 20887787006449 20887787006418 20887787006340 20887787006319 20887787006289 20887787006265 10887709102016 20887787006258 20887787005329 20887787005923 20887787005930 20887787005947 10887709004112 10887709055626 10887709083407 10887709083414 20887787009303 20887787009273 20887787009280 10887709120218 20887787009297 10840619024021 10840619024069 10840619024120 10840619064409 10887709085715 10887709051895 10887709040141 20887709120208 10887709020518 10887709020907 10887709022017 10887709022215 10887709022352 10887709022444 10887709022871 10887709022987 10887709023090 10887709023601 10887709024110 10887709024257 10887709024295 10887709024578 10887709024967 10887709026886 10887709028248 10887709028965 10887709028972 10887709030074 10887709031132 10887709031941 10887709032801 10887709033549 1088770903408 |
|---|
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
FDA Device · Class II · 2026-09-23 · Icu Medical - Oncology sets with drip chambers
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-3160-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.