Lower riskMedical device recall · FDA · Published December 19, 2025
ICU Medical Pulsator Arterial Blood Sampling Kit Recall: Cracks May Cause Blood Leakage
ICU Medical recalls specific Pulsator Arterial Blood Sampling Kits with possible cracks in syringe collars that could cause blood leakage or repeated blood draws during arterial sampling.
Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.
Take action
Contact the company
📍Recalling firmICU Medical Inc.6000 Nathan Ln N · Minneapolis, MN 55442-1690
“ICU Medical Pulsator Arterial Blood Sampling Kit Recall: Cracks May Cause Blood Leakage.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50380-icu-medical-pulsator-arterial-blood-sampling-kit-recall-cracks-may. Based on FDA recall #Z-1100-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1100-2026%22&limit=1).
The FDA announced on Dec. 19, 2025, that ICU Medical is voluntarily recalling Pulsator Arterial Blood Sampling Kits due to potential syringe collar cracks. The agency said the defect may cause blood leakage or delayed fluid delivery.
Distribution: US Nationwide in CA, FL, IL, IN, MA, MI, MN, MO, NE, NJ, NY, OH, OK, TX, WA
Units affected: 64,290
The hazard
According to the FDA, affected lots of syringes may have a crack on the syringe collar. This issue may lead to delayed or repeated blood draw/fluid delivery and blood leakage during sampling of arterial blood or leakage during fluid delivery.
Context
GovInfoNow's records show ICU Medical, Inc. has 60 other recalls on record since 2017-06-15. Other recent recalls include the 2026-08-20 ICU Medical CADD Yellow Medication Cassette Reservoir Recall and the 2026-06-24 ICU Medical Hotline Fluid Warming Set Recall. Similar recent recalls of comparable products include the 2026-06-15 Argon Medical L-Cath PICC Catheters Recall, the 2026-08-10 Fresenius Medical Care 5008X Blood Tubing Set Recall, and the 2026-01-08 Medline Dialysis Kits Recall.
How to tell if you have this one
Check the item numbers: 4044EG-1, 4080P-2, 4084P-1, 4080PE, or 4080PG. The specific lots listed in the recall notice are also affected.
Brand
ICU Medical
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution in the states of CA, FL, IL, IN, MA, MI, MN, MO, NE, NJ, NY, OH, OK, TX, WA.
Look for the item numbers 4044EG-1, 4080P-2, 4084P-1, 4080PE, or 4080PG on the kit packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 15 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of CA, FL, IL, IN, MA, MI, MN, MO, NE, NJ, NY, OH, OK, TX, WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Illinois, Indiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Texas, Washington.
Recall timeline
FDA published this recall 33 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1100-2026 (December 19, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1100-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.