Device recall: BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of…
Class II FDA enforcement event 96814. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Civco Medical Instruments Co. Inc. started this device recall on 1 May 2025. The firm address in the FDA record is in Kalona, IA. FDA put the recall in Class II. FDA event 96814 has 1 product record. The first FDA enforcement report date is 11 Jun 2025. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
OUS Distribution to countries of: Japan, Taiwan, France, Georgia, Germany and Denmark
Recalling firm
Civco Medical Instruments Co. Inc., Kalona, IA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1892-2025 | BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers | 506 boxes | Class II | Ongoing | 11 Jun 2025 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2025
- 945
- Share of these events in Class II
- 85%
- Product records in this event
- 1Median of the firm: 4
- Events of the firm on the register
- 7
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 2 Mar 2026 | eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149 | Device | Class II | 8 |
| 8 Oct 2021 | VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX | Device | Class II | 4 |
| 2 Nov 2018 | CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable non-sterile single-angle bracket | Device | Class II | 15 |
| 30 Jul 2018 | CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO | Device | Class II | 2 |
| 23 Feb 2018 | CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnost | Device | Class II | 1 |
| 21 Oct 2015 | CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, | Device | Class II | 5 |
Official channels
- FDA enforcement report Z-1892-2025The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 96814. https://recallregister.com/fda/ii/96814/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
OUS Distribution to countries of: Japan, Taiwan, France, Georgia, Germany and Denmark
- What quantity of product is in FDA event 96814?
- The FDA record gives this quantity:
506 boxes
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2025 have the same class?
- 85% of the 945 device events that started in 2025 are in Class II.