Skinny Needle with Chiba Tip — Class II medical device recall Z-0414-2022
Ongoing recall by Cook Inc., reported 2021-12-29, distributed nationwide. Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer
| Recall number | Z-0414-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2021-10-13 |
| Classified | 2021-12-22 |
| Reported by FDA | 2021-12-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | FR, IT, MX |
| UPC / GTIN / UDI-DI | 00827002142541 |
| Lot numbers | 090010-ET/GPN, 13977925, 14030949, 14038615, 14054162, 14116047, G15290 |
Product
Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced visualization of needle tip when used with ultrasonic imaging equipment.
Reason for recall
Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Local inflammatory reactions may occur if an affected product is used.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0414-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.