IV Sets with drip chambers
FDA Recall Z-3163-2026 · Posted 2026-09-11
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Recalling FirmICU Medical, Inc.
Recall StatusOpen, Classified
Product CodeFMG
Date Initiated2026-05-12
Product Quantity56,553,672
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.
Firm 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
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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