# FDA recall Z-1892-2025

> **Civco Medical Instruments Co. Inc.** · Class II · device recall initiated 2025-05-01.

## 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.

## Distribution

OUS Distribution to countries of: Japan, Taiwan, France, Georgia, Germany and Denmark

## Key facts

- **Recall number:** Z-1892-2025
- **Recalling firm:** Civco Medical Instruments Co. Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-01
- **Report date:** 2025-06-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Kalona, IA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1892-2025

## Citation

> AI Analytics. FDA recall Z-1892-2025. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-1892-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*