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, PREGNANT
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
- Biliary Exploration Set
- Model numbers
- Reference Part Number C-CSRC-7.5D-40-STRANGE, UDI (01)00827002091085(17)260221(10)15133690X, Lot Number 15133690X, UDI (01)00827002091085(17)260314(10)15274382, Lot Number 15274382, UDI (01)00827002091085(17)270104(10)15435573, Lot Number 15435573, UDI (01)00827002091085(17)270118(10)15445615 +3 more
- 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
The Cook Strange Bile Duct Stone Exploration Set is a surgical instrument used in biliary procedures. It helps explore stones in the bile ducts.
Why This Is Dangerous
Expiration labeling beyond shelf life could affect sterility or instrument performance, risking infection or procedure failure.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Direct impact on clinical procedures and patient safety; potential delays and need for device recalls in operating rooms.
Practical Guidance
How to identify if yours is affected
- Check Reference Part Number C-CSRC-7.5D-40-STRANGE on the device label
- Verify UDIs listed in recall materials
Where to find product info
FDA recall page and Cook Medical recall communications
What timeline to expect
Refunds/replacements processed per Cook Medical protocol, typically weeks to months
If the manufacturer is unresponsive
- Escalate to FDA recall contact
- File a complaint with FDA if the manufacturer does not respond
- Document all contact attempts
How to prevent similar issues
- Verify expiration labeling accuracy during procurement
- Use only devices with valid shelf life
- Maintain inventory controls to remove soon-to-expire items
- Refer to official FDA/ Cook Medical guidance during recalls
Documentation advice
Keep recall notices, batch/lot numbers, purchase records, and correspondence
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Product Details
Model: Reference Part Number C-CSRC-7.5D-40-STRANGE. UDI: 01 00827002091085 17 260221 10 15133690X and other UDIs for lot numbers 15133690X, 15274382, 15435573, 15445615, 15501690. Order Number G09108. Quantity: 49 units. Distribution: Worldwide.
Reported Incidents
No specific injuries or incidents are described in the recall notice.
Key Facts
- Part number C-CSRC-7.5D-40-STRANGE
- UDIs and lot numbers listed
- Expiration labeling exceeds shelf life
- Active recall as of 2026-03-05
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Safety Guide
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