FDA recall, , Moderate risk
ICU Medical IV Sets with Drip Chambers
IV Sets with drip chambers may have black specks which could result in a delay in therapy.
Summary by Recall Canary from the FDA notice
What happened
ICU Medical, Inc. began a recall of IV Sets with drip chambers on May 12, 2026, because the product may have black specks which could result in a delay in therapy. The recall was added to the FDA's Enforcement Report on August 26, 2026, and classified on September 2, 2026. The product was distributed in Alabama, Arizona, California, Colorado, Florida, Idaho, Indiana, Kansas, Minnesota, Missouri, North Carolina, Pennsylvania, Texas and Washington, and outside the U.S. in CA, PE.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for recalled products:
- Check the brand, package size and codes such as expiration dates against the notice.
- Return it to the store where you bought it, or dispose of it properly.
Is your set affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
IV Sets with drip chambers
- UDI-DI
- 10887709053783
- 10887709053905
- 10887709078267
- 10887709054100
- 10887709054230
- 10887709054414
- 10887709054445
- 10887709054476
- 10887709054636
- 10887709054711
- 10887709054742
- 10887709054803
- 10887709054810
- 10887709054827
- 10887709054834
- 10887709072050
- 10887709051512
- 10887709064192
- 10887709065205
- 10887709071060
- 10887709071367
- 10887709075655
- 10887709076270
- 10887709077802
- 10887709078458
- 10887709078489
- 10887709078519
- 10887709078700
- 10887709078809
- 10887709081465
- 10887709095301
- 10887709095318
- 10887709098319
- Lot code
- All products manufactured on or before 7/4/2026. UDI-DI: 10887709053783 10887709053905 10887709078267 10887709054100 10887709054230 10887709054230 10887709054414 10887709054445 10887709054476 10887709054636 10887709054711 10887709054742 10887709054803 10887709054810 10887709054827 10887709054834 10887709072050 10887709051512 10887709064192 10887709065205 10887709071060 10887709071367 10887709075655 10887709076270 10887709077802 10887709078458 10887709078489 10887709078519 10887709078700 10887709078809 10887709081465 10887709095301 10887709095318 10887709098319
Recall details
- Company began the recall
- Sold in
US: Arizona, Missouri, Florida, North Carolina, Washington, Minnesota, Colorado, Pennsylvania, Kansas, California, Alabama, Indiana, Idaho, Texas. OUS: California, PE
- Company
- ICU Medical, Inc.
- Hazard
- Device defect
- Risk
Moderate risk
It may cause short-term health problems in animals it is used on, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99688
- Recall number
- V-0190-2026
All recalls from ICU Medical, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Listed on Recall Canary
Classified by FDA · In FDA's weekly enforcement report
Summary updated
