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
- Syringe
- 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
- 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
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
- Check the item number on the syringe packaging.
- Look for the lot numbers A3729-24 UDI-DI 30351688075691 and A3595 UDI-DI 35019517108211.
- 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.
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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
- Cracks may cause leakage
- Immediate stop-use recommended
- Distributed in 13 US states
- No injuries reported
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