FDA-Device2026-04-15Class IIMISBRANDING

Cook Medical NCompass Nitinol Stone Extractor recalled for incorrect expiration dating

EXPIRATION DATE ERRORNationwide distributionMedical devices

What this means

Cook Medical's NCompass Nitinol Stone Extractor devices in certain lots were labeled with expiration dates that go beyond the actual shelf life of the product. This affects 70 units distributed worldwide. No injuries have been reported.

  • Check your Cook Medical NCompass stone extractor for Lot Number 15741134 or 15855141
  • Verify the labeled expiration date against the product's true shelf life before use
  • Contact Cook Medical or your supplier if you have affected devices
  • Do not use the device beyond its actual shelf life
The agency's original wording
Hazard

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

Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution.
Affected count
70 units
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1787-2026

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