Quick Facts at a Glance
- Recall Date
- March 5, 2026
- Hazard Level
- HIGH
- Brand
- Cook
- Category
- Health & Personal Care
- Sold At
- Unknown
- At-Risk Groups
- GENERAL, PREGNANT, ELDERLY
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
- Multipurpose Drainage Catheter
- Model numbers
- Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, UDI (01)00827002297753(17)261005(10)NS15690755, Lot Number NS15690755, UDI (01)00827002297753(17)260426(10)NS15408335, Lot Number NS15408335.
- Sold at
- Unknown
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 5, 2026
Reported by FDA DEVICE
April 15, 2026
RecallRadar source check
April 22, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
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: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
About This Product
This is a medical device used in drainage procedures. It is intended for hospital use and tangibly affects patient care.
Why This Is Dangerous
Labeling that overstates shelf life could lead to using expired devices, compromising sterility or effectiveness.
Industry Context
This recall is not indicated as part of a broader industry pattern.
Real-World Impact
The recall centers on labeling accuracy rather than device performance. Hospitals must verify lot numbers and expiry dates to prevent usage of potentially expired devices.
Practical Guidance
How to identify if yours is affected
- Check Part Number ULT8.5-38-25-P-CLMS-8-RH-FS
- Check Lot Numbers NS15690755 and NS15408335
- Verify expiry date on device labeling against hospital records
Where to find product info
FDA recall page and Cook Incorporated communications
What timeline to expect
Remedies are determined by Cook Incorporated; processing time varies by institution
If the manufacturer is unresponsive
- Escalate to hospital risk management
- Contact FDA recall information line
- Document all communications
How to prevent similar issues
- Implement standard quarantine for affected lots
- Enhance label verification during stocking
- Cross-check expiration against supplier records
Documentation advice
Maintain recall notice, purchase records, and disposition documentation
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Product Details
Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS. Order Number G29775. Quantity: 20 units. Distribution: Worldwide. Recall date: 2026-03-05. Status: ACTIVE.
Reported Incidents
No specific injuries or incidents are reported in the provided data.
Key Facts
- Hazard: expiration dates exceed true shelf life
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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