Recall Z-3157-2026
ICU Medical, Inc. · initiated May 12, 2026
Product
IV Non-Dedicated Gravity Administration Sets with drip chambers
Codes / lots: All products manufactured on or before 7/4/2026. UDI-DI: 10887709079363 10887709079370 10887709079417 10887709079431 10887709079448 10887709079455 10887709097473 10887709079493 10887709079509 10887709079547
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 that does not enter the fluid path, which if seen by a healthcare provider may lead to replacement of product before use, which could result in a delay in therapy.
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-3157-2026
- Initiated
- May 12, 2026
- Posted by FDA
- September 11, 2026
- Product code
- FMG – Stopcock, I.V. Set
- Quantity
- 2,450
- 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-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 |
| Z-3163-2026 | IV Sets with drip chambersIntravascular administration tubing set drip chambers may have black specks potentially due to the plastic… | 05/12/2026Open, Classified |