Z-3157-2026Class II

IV Non-Dedicated Gravity Administration Sets with drip chambers

Name: Z-3157-2026 IV Non-Dedicated Gravity Administration Sets with drip chambers
Creator: ICU Medical, Inc.
Published: 2026-05-12
License: https://open.fda.gov/license/

ICU Medical, Inc. / initiated 2026-05-12 / Open, Classified

FDA source

Recall record

Recall number: Z-3157-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-12
Posted: 2026-09-11
Recalling firm: ICU Medical, Inc.
Product: IV Non-Dedicated Gravity Administration Sets with drip chambers
Product code: FMG Stopcock, I.V. Set
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 root cause: Process control
Action: 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 [email protected] 3) Continue using products as intended and per facility protocol. 4) Report any product quality concerns to ICU Medical Complaint Management. Firm contacts: [email protected] 1-866-261-8806. [email protected] 1-800-258-5361
Quantity in commerce: 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.
Product codes and lots: All products manufactured on or before 7/4/2026. UDI-DI: 10887709079363 10887709079370 10887709079417 10887709079431 10887709079448 10887709079455 10887709097473 10887709079493 10887709079509 10887709079547

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3157-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3156-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-11
Z-3157-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-11
Z-3158-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-11
Z-3159-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-11
Z-3160-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-11
Z-3161-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-11
Z-3162-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-11
Z-3163-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-11

Product code FMG

K964435Class IIPrimary IV SetIcu Medical, Inc. / cleared 1997-04-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-15. View this recall on fda.gov (opens on fda.gov)