Civco Medical recalls BX2 Needle Guide (Part 644-094) due to risk of pinhole breaches in ultrasound transducers during assembly. Affected units have specific lot numbers and UDI-DI codes.
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.
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Contact the company
📍Recalling firmCivco Medical Instruments Co. Inc.102 1st St S · Kalona, IA 52247-9589
“Civco BX2 Needle Guide Recall: Pinhole Breach Risk in Ultrasound Transducers.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/52362-civco-bx2-needle-guide-recall-pinhole-breach-risk-in-ultrasound. Based on FDA recall #Z-1892-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1892-2025%22&limit=1).
The FDA announced on May 1, 2025, that Civco Medical Instruments Co. Inc. is recalling its BX2 Needle Guide, Part Number 644-094, due to a potential pinhole breach in the transducer cover. The hazard arises during attachment of the guide to the probe when latching it in place.
According to the FDA, the tight tolerance and fit of the needle guide can cause a pinhole breach in the transducer cover when latching the guide in place during attachment to the covered probe.
Context
GovInfoNow's records show Civco Medical Instruments Co. Inc. has five other recalls on record since Feb. 23, 2018. Other recent recalls of similar products include Sheathes3D Viral Barrier Ultrasound Probe Covers Recall (Nov. 17, 2025), Microvention Bobby Balloon Guide Catheter Recall (April 30, 2026), and Medtronic EOPA Arterial Cannula Recall (June 24, 2026).
How to tell if you have this one
Check for the part number 644-094 on the BX2 Needle Guide. Affected units have specific lot numbers listed in the recall notice and UDI-DI code 00841436120050.
Brand
Civco Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the part number 644-094 and UDI-DI code 00841436120050 on the device.
How this recall unfolded
Recall timeline
FDA published this recall 41 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1892-2025 (May 1, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1892-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.