Class II — Civco Medical Instruments Co. Inc.
| Recalling firm | CIVCO Medical Instruments Co., Inc. |
|---|---|
| Registered facility | CIVCO Medical Instruments Co., Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | During the attachment of the needle guide to the covered probe, the tight tolerance and fit of the needle guide can cause a pinhole breach in the transducer cover when latching the guide in place. |
| Product | BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers |
| Quantity | 506 boxes |
| Distribution | OUS Distribution to countries of: Japan, Taiwan, France, Georgia, Germany and Denmark |
| Initiated | 2025-05-01 |
| Classified | 2025-05-30 |
| Recall number | Z-1892-2025 |
| 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 — Civco Medical Instruments Co. Inc. (Z-1892-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96814/
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