BX2 Needle Guide — Class II medical device recall Z-1892-2025
Ongoing recall by Civco Medical Instruments Co. Inc., reported 2025-06-11, distributed in GA. During the attachment of the needle guide to the covered probe, the tight tolerance and fit of the needle guid
| Recall number | Z-1892-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Civco Medical Instruments Co. Inc., Kalona, IA, United States |
| Recall initiated | 2025-05-01 |
| Classified | 2025-05-30 |
| Reported by FDA | 2025-06-11 |
| Distributed | GA |
| Countries outside the US | DE, DK, FR, JP, TW |
| Quantity | 506 boxes |
| UPC / GTIN / UDI-DI | 00841436120050 |
| Lot numbers | A174424, A176855, A177208, A182744, A184023, A185336, A185337, A186904, A189734, A190489, A193623, A194755, A198716, A198795, A199940, A200430, A202208, A203169, A203201, A203520, A205457, A207901, A208740, A211619, A212291, A213027, A215531, A216885, A217412, A220102, A221365, A221925, A225145, A226800, A228446, A228778, A229092, A229898, A230045, A230054 and 35 more |
| Model numbers | 644-094 |
Product
BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers
Reason for recall
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.
Machine access
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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.