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Recall Observatory FDA recall evidence

Device product

COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Reference Part Number C-NTSE-2.4-115-NCT4, Order Number G36251.

Z-1787-2026

March 05, 2026

Class II

Product summary

Firm
Cook Incorporated
Event
Event 98495
Status
Ongoing
Classification
Class II
Quantity
70 units
Official record key
device-enforcement:Z-1787-2026

Official wording

Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Code information: 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.

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.