Recall Z-1892-2025— Civco Medical Instruments Co. Inc.

Name: FDA recall Z-1892-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-01

Class II · Ongoing

Class II FDA medical device recall by Civco Medical Instruments Co. Inc., initiated 2025-05-01. It names one FDA 510(k) clearance: K093713. Product: BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. 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..

Recalling firm: Civco Medical Instruments Co. Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-05-01
Firm location: Kalona, IA, United States

510(k) clearances named in this recall

1 on FDA's record

K093713 — ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEMCivco Medical Instruments·cleared 2010-01-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.