Quick Facts at a Glance
- Recall Date
- November 26, 2025
- Hazard Level
- HIGH
- Brand
- Cook
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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 Intrahepatic Access Set
- Model numbers
- 1) Reference Part Number RTPS-100: Order Number G06541, UDI (01)00827002065413(17)280722(10)16705779, Lot Number 16705779, 2) Reference Part Number RTPS-100-10.0: Order Number G29769, UDI (01)00827002297692(17)280624(10)16659044, Lot Number 16659044
- Sold at
- Unknown
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 Transjugular Intrahepatic Access Set is used for accessing the liver through the jugular vein for diagnostic and interventional procedures. Healthcare providers rely on this device for safe liver access in various medical scenarios.
Why This Is Dangerous
The recalled devices may have been manufactured incorrectly, leading to improper lengths or insufficient inspection. This defect poses a serious risk during medical procedures, potentially resulting in complications.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers using this device face potential health risks that could lead to serious complications during medical procedures. Immediate action is necessary to ensure safety.
Practical Guidance
How to identify if yours is affected
- Check the model numbers: RTPS-100 and RTPS-100-10.0.
- Refer to the recall notification letter for specific details on the affected lots.
- Verify with your healthcare provider if your device is affected.
Where to find product info
Serial numbers and lot numbers can typically be found on the packaging or directly on the device itself.
What timeline to expect
Refund processing timelines will be provided by Cook Medical upon contact.
If the manufacturer is unresponsive
- Document all communications with Cook Medical.
- Consider reaching out to regulatory bodies if issues persist.
How to prevent similar issues
- Inquire about the quality control measures of medical devices before purchase.
- Ask healthcare providers about the recall history of devices being used.
- Stay informed on recalls and safety alerts from the FDA.
Documentation advice
Keep copies of all correspondence regarding the recall, including receipts and notification letters.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recall affects two model numbers: RTPS-100 and RTPS-100-10.0. These medical devices were distributed worldwide. Each unit is intended for transjugular liver access during diagnostic and interventional procedures.
Key Facts
- Recall date: November 26, 2025
- Affected model numbers: RTPS-100, RTPS-100-10.0
- Quantity recalled: 15 units
- Classification: Class II
Browse More Recalls
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 ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.