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
- Needle Free Access Device
- Model numbers
- UDI-DI: 00840619026059, 00840619006785. REF/Lot(Expiration): 011-D1000/14015455(5/1/2029), 14044313(6/1/2029), 14228823(12/1/2029), 14274294(1/1/2030), 01C-D1000/14171414(10/1/2029), 14304670(2/1/2030), 055-D1000/13772668(9/1/2028) +12 more
- 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 28, 2026
RecallRadar source check
February 4, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may bulge at the top, separate from the body, tear; may result in fluid leaks, occluded fluid flow, inability to inject/withdraw blood product, delayed/interrupted therapy, exposure to biological contaminants, air infused into the body
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 Tego Connector is a needle-free access device used in hemodialysis and other intravascular procedures. Healthcare providers and patients rely on these devices to manage vascular access safely and effectively.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients may experience delayed or interrupted therapy, which can affect their health outcomes. The urgency of addressing this recall is high due to the potential for serious complications.
Practical Guidance
How to identify if yours is affected
- Check the model numbers of your Tego Connectors against the recalled list.
- Look for any signs of damage or malfunction, such as bulging or tearing of the silicone seal.
- Consult with your healthcare provider to confirm if your device is affected.
Where to find product info
Serial numbers and UDI codes can typically be found on the packaging or the device itself, usually near the base or on the label.
What timeline to expect
Expect a timeline of approximately 4-6 weeks for processing refunds or replacements once initiated.
If the manufacturer is unresponsive
- Document all correspondence with the manufacturer.
- Reach out to regulatory bodies like the FDA for further assistance.
- Consider consulting legal advice if unresolved.
How to prevent similar issues
- Ensure any medical devices used have recent certifications and are from reputable brands.
- Regularly check for product recalls and safety alerts from the FDA or other health organizations.
- Follow proper usage guidelines to minimize risks with medical devices.
Documentation advice
Keep records of all communications regarding the recall, including emails and phone call notes, along with your device's model number and purchase information.
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Product Details
The recall includes Tego Connectors with reference numbers 011-D1000, 01C-D1000, 055-D1000, D1000, and LAT-D1000. ICU Medical distributed approximately 14,684,607 units globally. These devices were sold in the U.S. and various international markets.
Key Facts
- Affected devices: Tego Connectors REF: 011-D1000, 01C-D1000, 055-D1000, D1000
- Total units recalled: 14,684,607
- High risk of fluid leaks and biological contamination
- Recall initiated on December 19, 2025
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Safety Guide
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