Quick Facts at a Glance
- Recall Date
- November 26, 2025
- Hazard Level
- HIGH
- Brand
- Cook
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- 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
- Cook
- Product type
- Transjugular Liver Access Set
- Model numbers
- Reference Part Number RUPS-100: Order Number G06929, UDI (01)00827002069299(17)280624(10)16659065, Lot Number 16659065
- Sold at
- Multiple Retailers
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 26, 2025
Reported by FDA DEVICE
December 31, 2025
RecallRadar source check
January 7, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Cook Incorporated or your healthcare provider for instructions. Notification method: Letter
About This Product
The R¿sch-Uchida Transjugular Liver Access Set is a medical device used for gaining access to the liver for diagnostic and interventional procedures. Healthcare providers use it in various liver-related treatments, making it essential for patient care.
Why This Is Dangerous
The manufacturing defects may result in the device being cut to the wrong length or improperly trimmed, increasing the risk of complications during procedures. Proper device specifications are critical for safe medical interventions.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
This recall may cause inconvenience for healthcare providers, necessitating the procurement of alternative devices. There is a heightened urgency for patient safety in medical procedures involving the liver.
Practical Guidance
How to identify if yours is affected
- Check the reference part number RUPS-100 and lot number 16659065 on the device packaging.
- Verify if your device matches the affected identifiers.
- Contact your healthcare provider for confirmation.
Where to find product info
The part number and lot number can usually be found on the packaging or the device itself, often near the barcode.
What timeline to expect
Expect a timeline of about 4-6 weeks for refund or replacement processing after returning the affected device.
If the manufacturer is unresponsive
- Contact Cook Incorporated again for follow-up.
- Document all communication attempts.
- Consider reaching out to regulatory bodies for assistance.
How to prevent similar issues
- Always verify product recalls through official channels before use.
- Ensure that medical devices meet safety regulations and standards before purchase.
- Consult with healthcare providers about alternative devices if recalls are issued.
Documentation advice
Keep copies of receipts, any communication related to the recall, and product identification details for your records.
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Product Details
The affected product is the R¿sch-Uchida Transjugular Liver Access Set, Reference Part Number RUPS-100. It was distributed worldwide. The order number is G06929, and the UDI is (01)00827002069299(17)280624(10)16659065.
Key Facts
- Recall date: November 26, 2025
- Quantity recalled: 23 units
- Products may have been cut to incorrect length
- Manufacturing defects could pose serious risks
- No injuries reported yet
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