FDA Device recall Z-3163-2026
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-3163-2026 |
| 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:10840619000025 10840619000049 10840619004481 10840619004498 108…All products manufactured on or before 7/4/2026. UDI-DI:10840619000025 10840619000049 10840619004481 10840619004498 10840619004627 10840619099371 10887709095981 10887709093864 10087219126704 10840619060081 10887709070124 10887709123516 10887709124643 10887709090696 10887709124414 10887709066318 10887709089812 10887709090702 10887709120171 10887709120188 10887709122892 10887709122441 10887709123905 10887709124537 10887709126739 10887709095240 10887709095707 10887709124018 10887709085432 10887709086002 10887709088495 10887709088501 10887709088518 10887709089393 10887709089904 10887709091754 10887709091990 10887709095271 10887709121147 10887709128221 10887709003610 10887709003627 10887709003634 10887709003672 10887709003696 10887709003733 10887709003740 10887709003757 10887709003764 10887709051550 10887709050409 10887709003894 10887709003924 10887709003931 10887709003986 10887709003993 10887709084060 10887709004020 10887709004037 10887709055404 10887709004075 10887709004082 10887709074016 |
|---|
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-3163-2026%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.