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CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures w...

FDA Device Recall #Z-2888-2018 — Class II — February 23, 2018

Recall Summary

Recall Number Z-2888-2018
Classification Class II — Moderate risk
Date Initiated February 23, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Civco Medical Instruments Co. Inc.
Location Kalona, IA
Product Type Devices
Quantity 177 boxes

Product Description

CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. Product Usage: The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers.

Reason for Recall

A cover failed leak testing during validation testing of new needle guides from a replacement tool.

Distribution Pattern

Worldwide Distribution - US Nationwide in the states of GA, KY, CA, NY , NJ, TX, IL, MA, RI, AZ, and IA and countries of Ukraine, Hong Kong, Italy, Netherlands, Switzerland, United Kingdom, Denmark, Germany, Belgium, Spain, Japan, China, and Canada

Lot / Code Information

Item: 639-026 - Biopsy Starter Kit for use with Esaote LA332 and SL332 transducers Lot #'s M206950, M664690, M897110, M119380, M605540, M706720, M570610, M543670, M851530, M983170, M358570. M358570, M427660. M526300, M526300, M734570, M912740, and M664690. Item 698-009: Biopsy Starter Kit for use with Zonare C9-3 transducers M427370, M103030, A010473, M103030, M771190, M427390, M293590, M427370, M105150, M089260, M515370, M293580, M888920, M427370, M220960, M558420, M560740, M909270, M096330, M388690, M558220, M695400, M085550, M917410, M419650, M879530, M964370, M093020, M723180, and A010459 Item: 698-016 Biposy Bracket for use with Zonare C9-3 transducers M567620 and M052860 Item 620-116 Biopsy Starter Kit for use with BK Medical 18L5 and 8870 transducers M080890, M559550, M425050, M056610, M092800, M041630, M186540, M122250, M335740, M043310, M499390, M483250, M109060, M275630, M912150, A023904, M457560, M051670, M091360, M895560, A015235, M202260, M869430, M056610, M027090, M308820, M831280, M547370, M253050, M083160, and M865470

Other Recalls from Civco Medical Instruments Co. Inc.

Recall # Classification Product Date
Z-1892-2025 Class II BX2 Needle Guide, Part Number 644-094, tool for... May 1, 2025
Z-0395-2022 Class II VirtuTRAX Instrument Navigator, Sensor with 14 ... Oct 8, 2021
Z-0397-2022 Class II VirtuTRAX Instrument Navigator, Sensor with 10 ... Oct 8, 2021
Z-0398-2022 Class II VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX Oct 8, 2021
Z-0396-2022 Class II VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX Oct 8, 2021

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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