HIGH

ICU Medical Recalls Spinal Tray Syringes Due to Leakage Risk

ICU Medical recalled 64,290 spinal tray syringes on December 19, 2025, due to potential cracks in the syringe collar. The cracks may cause blood leakage and delays in blood draws or fluid delivery. Affected syringes were distributed nationwide across 13 states.

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

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

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About This Product

Portex spinal tray syringes are used in medical settings for blood draws and fluid delivery. Healthcare providers purchase these syringes for their reliability and effectiveness in critical procedures.

Why This Is Dangerous

Cracks in the syringe collar can compromise the device's integrity, leading to improper blood draws or fluid delivery. This can pose significant risks during medical procedures.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall may cause inconvenience for healthcare providers who rely on these syringes for patient care. Immediate action is necessary to avoid potential complications.

Practical Guidance

How to identify if yours is affected

  1. Check the item number on the syringe packaging.
  2. Look for the lot numbers A3729-24 UDI-DI 30351688075691 and A3595 UDI-DI 35019517108211.
  3. Confirm the syringes are within the specified recall dates.

Where to find product info

The item number and lot numbers can typically be found on the product packaging or label attached to the syringe itself.

What timeline to expect

Expect a response for refunds or replacements within 4-6 weeks.

If the manufacturer is unresponsive

  • Document all communication attempts with ICU Medical.
  • Consider reaching out to the FDA for further assistance.
  • File a complaint with consumer protection agencies if necessary.

How to prevent similar issues

  • Always check for recalls on medical devices before use.
  • Look for the latest safety certifications when purchasing syringes.
  • Be aware of any changes in device instructions or warnings.

Documentation advice

Keep records of your purchase, communication with the manufacturer, and any photographs of the recalled product.

Product Details

The recall involves Portex Spinal Tray syringes, Item No. A3729-24 and A3595. The affected lots include A3729-24 UDI-DI 30351688075691 (Lot 6146204) and A3595 UDI-DI 35019517108211 (Lot 6157980). The syringes were distributed in California, Florida, Illinois, Indiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Texas, and Washington.

Key Facts

  • 64,290 syringes recalled
  • Cracks may cause leakage
  • Immediate stop-use recommended
  • Distributed in 13 US states
  • No injuries reported

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
1. A3729-24 UDI-DI 30351688075691 Lots 6146204 (corrected on 1/22/26
removed "-LSM" suffix. 2. A3595 UDI-DI 35019517108211 Lot 6157980
Affected States
ALL
Report Date
January 21, 2026
Recall Status
ACTIVE

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