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Civco Medical Instruments Co. Inc.

Complete recall history across all FDA and CPSC categories — 13 total recalls

Civco Medical Instruments Co. Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (13)

FDA medical device enforcement actions by Civco Medical Instruments Co. Inc.

Date Product Reason Class
May 1, 2025 BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or ... During the attachment of the needle guide to the covered probe, the tight tol... Class II
Oct 8, 2021 VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX There is potential that the VirtuTRAX device will not tighten onto the instru... Class II
Oct 8, 2021 VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX There is potential that the VirtuTRAX device will not tighten onto the instru... Class II
Oct 8, 2021 VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX There is potential that the VirtuTRAX device will not tighten onto the instru... Class II
Oct 8, 2021 VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX There is potential that the VirtuTRAX device will not tighten onto the instru... Class II
Jul 30, 2018 CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO The assembly of the needle guides were found to be either missing adhesive or... Class II
Jul 30, 2018 CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO The assembly of the needle guides were found to be either missing adhesive or... Class II
Feb 23, 2018 CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or ca... A cover failed leak testing during validation testing of new needle guides fr... Class II
Oct 21, 2015 CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STE... Sterility of the product cannot be assured. Class II
Oct 21, 2015 CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Pl... Sterility of the product cannot be assured. Class II
Oct 21, 2015 CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Gu... Sterility of the product cannot be assured. Class II
Oct 21, 2015 CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking br... Sterility of the product cannot be assured. Class II
Oct 21, 2015 CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12... Sterility of the product cannot be assured. Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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