Recall Z-3163-2026
ICU Medical, Inc. · initiated May 12, 2026
Product
IV Sets with drip chambers
Codes / lots: 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 10887709004099 10887709004129 10887709004167 10887709004358 10887709004365 10887709004389 10887709004518 10887709004525 10887709004549 10887709004563 10887709004570 10887709004792 10887709004808…
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.
FDA-determined cause: Process control
Action taken
On 5/12/2026, the firm posted a Information Regarding Reported Black Specks in Certain IV Tubing Set Drip Chambers from ICU Medical document on their website. On 5/18/2026, updated the notices were sent. On 7/28/2026, correction notices were sent to customers asking them to do the following: 1) Share this notification with all potential users of the device to ensure they are aware of this notification. If the devices are used or further distributed to another location, please ensure that this communication is delivered there. 2) Complete and return the attached Customer Response Form to MarketAction@mailac.custhelp.com 3) Continue using products as intended and per facility protocol. 4) Report any product quality concerns to ICU Medical Complaint Management. Firm contacts: GlobalComplaints@icumed.com 1-866-261-8806. customerservice@icumed.com 1-800-258-5361
Details
- Recall number
- Z-3163-2026
- Initiated
- May 12, 2026
- Posted by FDA
- September 11, 2026
- Product code
- FMG – Stopcock, I.V. Set
- Quantity
- 56,553,672
- 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, 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.
- Recalling firm
- ICU Medical, Inc., San Clemente, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3156-2026 | Plum administration setsIntravascular administration tubing set drip chambers may have black specks potentially due to the plastic… | 05/12/2026Open, Classified |
| Z-3157-2026 | IV Non-Dedicated Gravity Administration Sets with drip chambersIntravascular administration tubing set drip chambers may have black specks potentially due to the plastic… | 05/12/2026Open, Classified |
| Z-3158-2026 | Oncology sets with drip chambersIntravascular administration tubing set drip chambers may have black specks potentially due to the plastic… | 05/12/2026Open, Classified |
| Z-3159-2026 | Oncology sets with drip chambersIntravascular administration tubing set drip chambers may have black specks potentially due to the plastic… | 05/12/2026Open, Classified |
| Z-3160-2026 | IV Sets with drip chambersIntravascular administration tubing set drip chambers may have black specks potentially due to the plastic… | 05/12/2026Open, Classified |
| Z-3161-2026 | IV Sets with drip chambersIntravascular administration tubing set drip chambers may have black specks potentially due to the plastic… | 05/12/2026Open, Classified |
| Z-3162-2026 | IV Sets with drip chambersIntravascular administration tubing set drip chambers may have black specks potentially due to the plastic… | 05/12/2026Open, Classified |