Z-1892-2025Class II

BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the...

Name: Z-1892-2025 BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the...
Creator: Civco Medical Instruments Co. Inc.
Published: 2025-05-01
License: https://open.fda.gov/license/

CIVCO Medical Instruments Co., Inc. / initiated 2025-05-01 / Open, Classified / root cause: manufacturing process

FDA source

Civco Medical Instruments Co. Inc. began a recall of BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers on 2025-05-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1892-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-01
Posted: 2025-05-30
Recalling firm: CIVCO Medical Instruments Co., Inc.
Product: BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers
Product code: ITX Transducer, Ultrasonic, Diagnostic
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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: An URGENT: MEDICAL DEVICE RECALL notification letter dated 5/1/25 was sent to customers. Actions to be taken by the Customer/User: CIVCO requests that you check your inventory for any BX2 Needle Guides and complete the supplied response letter for the appropriate action. Please contact your distribution partner to return any existing inventory or report its destruction by completing the attached response form. Please complete the enclosed response form even if you do not have any BX2 Needle Guides remaining in your inventory to assist in our reconciliation process. Response forms can also be sent via email to [email protected]. Type of Action by the Company: This notice is being communicated to all customers who have purchased a BX2 Needle Guide from affected lots. CIVCO requests you provide this notification to the appropriate personnel within your facility. If the affected product was distributed outside of your organization, please notify those locations down to the medical facility level. PLEASE SEND COMPLETED RESPONSE FORM to email to [email protected]. If you have any questions, call 319-248-6502 or email: [email protected].
Quantity in commerce: 506 boxes
Distribution: OUS Distribution to countries of: Japan, Taiwan, France, Georgia, Germany and Denmark
Product codes and lots: UDI-DI: 00841436120050; Lot Numbers: A174424, A176855, A177208, A182744, A184023, A185336, A185337, A186904, A189734, A190489, A193623, A194755, A198716, A198795, A199940, A200430, A202208, A203169, A203201, A203520, A205457, A207901, A208740, A211619, A212291, A213027, A215531, A216885, A217412, A220102, A221365, A221925, A225145, A226800, A228446, A228778, A229092, A229898, A230045, A230054, A230549, A230581, A231101, A231810, A232903, A233075, A233535, A236538, A238767, A239339, A239355, A240873, A240931, A241445, A242018, A242161, A243263, A243264, A245342, A245527, A246173, A248520, A248572, A250325, A252513, A252842, A254080, A254081, A254900, A254955, A255332, A257534, A258150, A258926, A260607

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1892-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1892-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-11	2025-05-30

Product code ITX

K093713Class IIUltrasound General Purpose Guidance SystemCivco Medical Instruments / cleared 2010-01-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)