Civco Medical Instruments Co. Inc. recalls BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic…
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.
Read the official notice →- Date
- 2025-06-11
- Country
- United States
- Brand
- Civco Medical Instruments
- Product
- BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound…
- Classification
- Class II
- Units
- OUS Distribution to countries of: Japan, Taiwan, France, Georgia, Germany and…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Civco Medical Instruments recalls
- 2026-04-08
US
Civco Medical Instruments Co. Inc. recalls eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
- 2021-12-29
US
Civco Medical Instruments Co. Inc. recalls VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX
There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
FDA · DeviceCivco Medical Instruments Co. Inc.Worldwide distribution - US Nationwide and the countries of Belgium, Canada,…Official notice →
Other drugs & medical recalls in the United States
- 2025-06-11
US
Luminex Corporation recalls VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System;…
It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges.
FDA · DeviceLuminex CorporationUS Nationwide distribution in the states of AL, CA, MN, TX, AZ, NJ, WA, SC,…Official notice →US
Beckman Coulter, Inc. recalls Access Testosterone assay, Catalog Number 33560
Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to splashing (cross-contamination) between the wells of testosterone reagent packs lot 538081, which could potentially result…
US
Silex Medical, LLC recalls Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF…
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
FDA · DeviceSilex Medical, LLCUS Nationwide distribution in the states of Florida, North Dakota, Illinois,…Official notice →US
Foundation Medicine, Inc. recalls FoundationOne Companion Diagnostic (F1CDx)
An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report.
FDA · DeviceFoundation Medicine, Inc.US Nationwide distribution in the state of WI.Official notice →US
Foundation Medicine, Inc. recalls FoundationOne Companion Diagnostic (F1CDx)
Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant information was displayed correctly in the tumor profiling section of both FDA-approved test reports.
FDA · DeviceFoundation Medicine, Inc.US Nationwide distribution in the state of MI.Official notice →US
Mozarc Medical US LLC recalls Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Potential breach of sterile barrier packaging.
FDA · DeviceMozarc Medical US LLCWorldwide distribution - US Nationwide and the countries of Canada & Mexico.Official notice →