Reported Jun 11, 2025 · Ongoing
BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of…
Civco Medical Instruments Co. Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Civco Medical Instruments Co. Inc. · 102 1st St S · Kalona, IA · 52247-9589
Is this the product you have?
- BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers
- Lot codes and dates
- UDI-DI00841436120050
- Lot Numbers
75 of 75 codes
A174424A176855A177208A182744A184023A185336A185337A186904A189734A190489A193623A194755A198716A198795A199940A200430A202208A203169A203201A203520A205457A207901A208740A211619A212291A213027A215531A216885A217412A220102A221365A221925A225145A226800A228446A228778A229092A229898A230045A230054A230549A230581A231101A231810A232903A233075A233535A236538A238767A239339A239355A240873A240931A241445A242018A242161A243263A243264A245342A245527
- Amount recalled
- 506 boxes
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Civco Medical Instruments Co. Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.