IV Non-Dedicated Gravity Administration Sets with drip chambers: recall status
Notice names this product. ICU Medical’s IV Non-Dedicated Gravity Administration Sets with drip chambers is named in FDA Class II recall Z-3157-2026.
Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies.Agency-reported hazard: 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. Identifying details: All products manufactured on or before 7/4/2026. UDI-DI: 10887709079363 10887709079370 10887709079417 10887709079431 10887709079448 10887709079455 10887709097473 10887709079493 10887709079509 10887709079547. Units affected: 2,450. Status: Ongoing.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Product named
IV Non-Dedicated Gravity Administration Sets with drip chambers
Company / brand
ICU Medical
Lot / serial / date codes
All products manufactured on or before 7/4/2026. UDI-DI: 10887709079363 10887709079370 10887709079417 10887709079431 10887709079448 10887709079455 10887709097473 10887709079493 10887709079509 10887709079547
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.
Agency product description and boundaries
IV Non-Dedicated Gravity Administration Sets with drip chambers
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material with…