FDA DevicesClass II
COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2....
Published: April 15, 2026Recall ID: Z-1787-2026Category: devicesCountry: US
Reason for Recall / Hazard
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Product Description & Identification
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.
Affected 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.
Additional Source Details
| Field | Value |
|---|---|
| City | Bloomington |
| State | IN |
| Event id | 98495 |
| Address 1 | 750 N Daniels Way |
| Code info | 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. |
| Postal code | 47404-9120 |
| Report date | 20260415 |
| Product type | Devices |
| Product quantity | 70 units |
| Reason for recall | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260305 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260406 |
Overview
- Recalling FirmCook Incorporated
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution.