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Cook Medical NCompass Nitinol Stone Extractor Recalled Over Expiration Date Shelf-Life Concerns (202

Cook Medical recalled 70 NCompass nitinol stone extractors worldwide after labeling showed expiration dates that exceed their true shelf life. The recall affects lots labeled C-NTSE-2.4-115-NC3 (G36250) and C-NTSE-2.4-115-NCT4 (G36251). The company classifies the action as Class II and says the issue could affect patient safety.

Official notice
CookHealth & Personal CareMedical DevicesReference Part Number C-NTSE-2.4-115-NC3UDI (01)00827002362505(17)261103(10)15741134Lot Number 15741134

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
March 5, 2026
Status
ACTIVE
Severity
8/10

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

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 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
Nitinol Stone Extractor
Model numbers
Reference Part Number C-NTSE-2.4-115-NC3, UDI (01)00827002362505(17)261103(10)15741134, Lot Number 15741134, Reference Part Number C-NTSE-2.4-115-NCT4, UDI (01)00827002362512(17)270118(10)15855141, Lot Number 15855141.
Sold at
Unknown

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    March 5, 2026

  2. Reported by FDA DEVICE

    April 15, 2026

  3. RecallRadar source check

    April 22, 2026

  4. 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 NCompass Nitinol Stone Extractor is a medical device used in stone retrieval procedures. It is designed for healthcare settings to aid in extracting stones.

Why This Is Dangerous

Expired shelf-life labeling may compromise the device's reliability during medical procedures, posing safety risks.

Industry Context

This recall is not identified as part of a broader industry pattern.

Real-World Impact

Direct impact on patients undergoing stone extraction procedures; clinicians should verify expiration status before use.

Practical Guidance

How to identify if yours is affected

  1. Check Part Numbers: C-NTSE-2.4-115-NC3 and C-NTSE-2.4-115-NCT4
  2. Check Lot Numbers: 15741134 and 15855141
  3. Verify expiration labeling against true shelf life on documentation

Where to find product info

FDA recall page and Cook Medical recall communications

What timeline to expect

Remedies and replacements will follow Cook's recall protocol; no specific window provided in data

If the manufacturer is unresponsive

  • Escalate to hospital risk management
  • File report with FDA if manufacturer is unresponsive

How to prevent similar issues

  • Careful inventory management
  • Regularly validate expiration labeling against shelf life
  • Coordinate with procurement to replace affected lots

Documentation advice

Keep recall notices, lot and part numbers, and all correspondence with healthcare providers and Cook Medical

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Product Details

Product: Cook Medical NCompass Nitinol Stone Extractor. Reference Part Numbers: C-NTSE-2.4-115-NC3 (G36250) and C-NTSE-2.4-115-NCT4 (G36251). Quantity: 70 units. Distribution: Worldwide. Recall date: 2026-03-05. Manufacturer: Cook Incorporated. Status: Active.

Reported Incidents

No specific incidents or injuries are reported in the provided data.

Key Facts

  • Class II recall
  • Expiration dates exceed shelf life
  • Part numbers C-NTSE-2.4-115-NC3 and C-NTSE-2.4-115-NCT4
  • Lot numbers 15741134 and 15855141

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 Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANT
Injury Types
ELECTRICALOTHER

Product Details

Brand
Model Numbers
Reference Part Number C-NTSE-2.4-115-NC3
UDI (01)00827002362505(17)261103(10)15741134
Lot Number 15741134
Reference Part Number C-NTSE-2.4-115-NCT4
UDI (01)00827002362512(17)270118(10)15855141
+1 more
Report Date
April 15, 2026
Recall Status
ACTIVE

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