Quick Facts at a Glance
- Recall Date
- December 19, 2025
- Hazard Level
- HIGH
- Brand
- ICU Medical
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- ICU Medical
- Product type
- Pulsator Arterial Blood Sampling Kit
- Model numbers
- 1. 4044EG-1 UDI-DI 30351688073062 Lots 6141992 6156228 2. 4080P-2 UDI-DI 30351688006176 Lots 6141999 6142000 6147906 3. 4084P-1 UDI-DI 30351688029540 Lots 6147907 (corrected 1/22/26, removed "-LSM" suffix) 4. 4080PE UDI-DI 30351688039150 Lot 6131839 5. 4080PG UDI-DI 30351688081173 Lots 6131838 6142001 6142002
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 19, 2025
Reported by FDA DEVICE
January 21, 2026
RecallRadar source check
January 28, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact ICU Medical Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
The Pulsator Arterial Blood Sampling Kit is used for drawing arterial blood and delivering fluids in medical settings. Healthcare providers rely on these kits for accurate blood sampling during various procedures.
Why This Is Dangerous
A crack in the syringe collar can disrupt the integrity of the syringe, leading to potential blood leakage during use. This defect poses risks for both patients and healthcare providers.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall poses an urgent issue for healthcare providers relying on these kits for patient care, risking inconvenience and potential safety hazards.
Practical Guidance
How to identify if yours is affected
- Check the item number on your Pulsator Arterial Blood Sampling Kit to see if it matches the affected models.
- Inspect the syringe collar for any visible cracks or defects.
- Verify if you received a recall notification letter from ICU Medical.
Where to find product info
You can find the item number on the packaging and the syringes themselves. The UDI-DI numbers are also listed in the recall information.
What timeline to expect
Expect a realistic timeline of 4-6 weeks for refund processing after returning the product.
If the manufacturer is unresponsive
- Document all attempts to contact ICU Medical Inc.
- Reach out to the FDA for assistance if the company does not respond.
How to prevent similar issues
- Look for medical devices with robust safety features and certifications.
- Research the brand's recall history before purchasing medical supplies.
- Consult with healthcare professionals about recommended brands and products.
Documentation advice
Keep copies of your recall notification letter, any correspondence with ICU Medical, and receipts related to your purchase.
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Product Details
The recall involves ICU Medical's Pulsator Arterial Blood Sampling Kit, specifically item numbers 4044EG-1, 4080P-2, 4084P-1, 4080PE, and 4080PG. The kits were distributed across various states including California, Florida, and Texas.
Key Facts
- Affected item numbers include 4044EG-1, 4080P-2, 4084P-1, 4080PE, 4080PG
- Potential crack in syringe collar
- Risk of blood leakage during sampling
- Contact ICU Medical for further instructions
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Safety Guide
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