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.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
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
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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.
Expired shelf-life labeling may compromise the device's reliability during medical procedures, posing safety risks.
This recall is not identified as part of a broader industry pattern.
Direct impact on patients undergoing stone extraction procedures; clinicians should verify expiration status before use.
FDA recall page and Cook Medical recall communications
Remedies and replacements will follow Cook's recall protocol; no specific window provided in data
Keep recall notices, lot and part numbers, and all correspondence with healthcare providers and Cook Medical
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.
No specific incidents or injuries are reported in the provided data.
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