Class II — Cook Inc.
| Recalling firm | COOK, INC. |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| 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. |
| Quantity | 112 US, 240 OUS |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AL, CA, IN, LA, MS, MT, NC, NY, OR, PA, WA and the countries of France, Italy, and Mexico. |
| Initiated | 2021-10-13 |
| Classified | 2021-12-22 |
| Recall number | Z-0414-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Cook Inc. (Z-0414-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89104/
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