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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

ICU Medical Sampling Kits and Spinal Trays Recalled for Syringe Cracks

Agency Publication Date: January 15, 2026
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Summary

ICU Medical Inc. is recalling approximately 64,290 units of Pulsator Arterial Blood Sampling Kits and Portex Spinal Trays. The syringes included in these kits may have a crack on the collar, which can lead to fluid or blood leakage during use. This defect may also cause delays in critical medical procedures or require repeated blood draws.

Risk

A cracked syringe collar can cause blood to leak during sampling or fluid to leak during delivery, potentially exposing healthcare workers to bloodborne pathogens. It also risks inadequate treatment or delayed results for the patient.

What You Should Do

  1. This recall affects Pulsator Arterial Blood Sampling Kits (Item Numbers 4044EG-1, 4080P-2, 4084P-1, 4080PE, 4080PG) and Portex Spinal Trays (Item Numbers A3729-24, A3595).
  2. Check the item number and lot number printed on your product packaging. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately.
  4. Contact ICU Medical Inc. or your distributor to arrange return, replacement, or correction.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for more information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Pulsator Arterial Blood Sampling Kit
Model / REF:
4044EG-1
4080P-2
4084P-1
4080PE
4080PG
Lot Numbers:
6141992
6156228
6141999
6142000
6147906
6147907
6131839
6131838
6142001
6142002
UDI:
30351688073062
30351688006176
30351688029540
30351688039150
30351688081173

Item 4084P-1 corrected to remove '-LSM' suffix from lot records.

Product: Portex Spinal Tray
Model / REF:
A3729-24
A3595
Lot Numbers:
6146204
6157980
UDI:
30351688075691
35019517108211

Item A3729-24 corrected to remove '-LSM' suffix from lot records.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98168
Status: Active
Manufacturer: ICU Medical Inc.
Sold By: authorized distributors; hospitals; clinical facilities
Manufactured In: United States
Units Affected: 2 products (64290 total)
Distributed To: California, Florida, Illinois, Indiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Texas, Washington
Agency Last Updated: January 22, 2026

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.