IV Sets with drip chambers recallZ-3161-2026 · ICU Medical, Inc. · initiated May 12, 2026

Why it was recalled

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 root cause category: Process control

What the company is doing

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

Recall details

Recall number

Z-3161-2026

Status

Open, Classified

Initiated by the company

May 12, 2026

Posted by the FDA

Sep 11, 2026

Recalling firm

ICU Medical, Inc.

Quantity

6,105,468

Product code

ONB

FDA submissions

K131549, K170110, K173477

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 description

IV Sets with drip chambers

Devices named in this recall

23 devices in the FDA device registry whose identifier appears in the recall's code information.

• ICU Medical CL3011

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  3 recalls26 reports
• ICU Medical CL3511

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  3 recalls6 reports
• ICU Medical CL4130

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  2 recalls6 reports
• ICU Medical CL4131

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  2 recalls6 reports
• ICU Medical CH3011

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall12 reports
• ICU Medical CL3520

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall3 reports
• ICU Medical 20121-01

  Icu Medical, Inc. · Set, administration, intravascular
  1 recall0 reports
• ICU Medical 20127-01

  Icu Medical, Inc. · Set, administration, intravascular
  1 recall0 reports
• ICU Medical CH3020

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CH3299

  Icu Medical, Inc. · Set, administration, intravascular
  1 recall0 reports
• ICU Medical CH4001

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CH3453

  Icu Medical, Inc. · Set, administration, intravascular
  1 recall0 reports
• ICU Medical CL4001

  Icu Medical, Inc. · Set, administration, intravascular
  1 recall0 reports
• ICU Medical CH3537

  Icu Medical, Inc. · Set, administration, intravascular
  1 recall0 reports
• ICU Medical CL3294

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CL3978

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CL4100

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CH3760

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CL3020T

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CL3011T

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CL3028T

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CL3528T

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports
• ICU Medical CL4160

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  1 recall0 reports

Other devices under the same FDA submission

97 devices cleared under K131549, K170110, K173477 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• ICU Medical CL4136

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  3 recalls1 report
• ICU Medical CL-80

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  3 recalls0 reports
• ICU Medical CL3900

  Icu Medical, Inc. · Set, administration, intravascular
  3 recalls0 reports
• ICU Medical CL3960

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  2 recalls26 reports
• ICU Medical CL-80S

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  2 recalls5 reports
• ICU Medical CL-82

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  2 recalls3 reports
• ICU Medical CL-80S-5

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  2 recalls2 reports
• ICU Medical CL-72

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  2 recalls1 report
• ICU Medical CL-70S

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  2 recalls1 report
• ICU Medical CL-10-10

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  2 recalls1 report
• ICU Medical CL-70

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  2 recalls0 reports
• ICU Medical CL-70-10

  Icu Medical, Inc. · Closed antineoplastic and hazardous drug reconstitution and transfer system
  2 recalls0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 99058).

• Z-3156-2026 · Open, Classified
  Plum administration sets
• Z-3157-2026 · Open, Classified
  IV Non-Dedicated Gravity Administration Sets with drip chambers
• Z-3158-2026 · Open, Classified
  Oncology sets with drip chambers
• Z-3159-2026 · Open, Classified
  Oncology sets with drip chambers
• Z-3160-2026 · Open, Classified
  IV Sets with drip chambers
• Z-3162-2026 · Open, Classified
  IV Sets with drip chambers
• Z-3163-2026 · Open, Classified
  IV Sets with drip chambers