Lower risk Medical device recall · FDA · Published February 23, 2018

Civco Needle Guide Bracket Recall: Cover Leak Risk

Civco recalls Infinity Needle Guide Brackets due to potential cover leaks during validation testing. Affected units include specific biopsy starter kits with listed lot numbers. Consumers should contact Civco for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2888-2018Medical device Civco ›

Lower-risk recall

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

Take action

Contact the company

Recalling firmCivco Medical Instruments Co. Inc.102 1st St S · Kalona, IA 52247-9589

✎ GovInfoNow plain-language explainer

Civco is recalling its Infinity Needle Guide Brackets because a cover failed leak testing during validation of new needle guides. This could lead to improper use during medical procedures if the bracket leaks. Read more at govinfonow.com/recall/71876-civco-needle-guide-bracket-recall-cover-leak-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/71876-civco-needle-guide-bracket-recall-cover-leak-risk · Updated August 27, 2026 · FDA enforcement record: FDA #Z-2888-2018

Cite this page

“Civco Needle Guide Bracket Recall: Cover Leak Risk.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/71876-civco-needle-guide-bracket-recall-cover-leak-risk. Based on FDA recall #Z-2888-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2888-2018%22&limit=1).

The Food and Drug Administration announced on Feb. 23, 2018, that Civco Medical Instruments Co. Inc. is recalling the CIVCO lnfiniti Needle Guide Bracket due to a cover leak testing failure. The agency stated the recall affects 177 boxes distributed worldwide.

How to tell if you have it

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

The hazard

A cover failed leak testing during validation testing of new needle guides from a replacement tool. The product is used for performing needle-guided or catheter procedures with diagnostic ultrasound transducers.

Context

GovInfoNow's records show Civco Medical Instruments Co. Inc. has issued five other recalls since July 30, 2018. Other recent recalls of similar products include Merit Medical Splashwire Hydrophilic Guide Wire Recall (May 8, 2026), Sheathes3D Viral Barrier Ultrasound Probe Covers Recall (Nov. 17, 2025), and Olympus HX-400U-30 Ligating Device Recall (Oct. 30, 2025).

How to tell if you have this one

Check for the product name 'CIVCO lnfiniti Needle Guide Bracket' with specific biopsy starter kits listed in the recall notice. Lot numbers include M206950, M66469: M897110, and others as detailed in the recall.

Brand
Civco
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Contact Civco
Reach out to Civco Medical Instruments Co. Inc. for details about the affected units and next steps.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 11 states.

FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, California, Georgia, Illinois, Iowa, Kentucky, Massachusetts, New Jersey, New York, Rhode Island, Texas.

Recall timeline

FDA terminated this recall 2.6 years after the firm started it.

Feb 23, 2018Firm started the recall
Aug 22, 2018FDA classified it Class II
Aug 29, 2018Published in FDA’s Enforcement Report
Oct 6, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

How can I check if my product is affected?

Check the lot numbers on your product against the list provided in the recall notice, which includes specific biopsy starter kits and their associated lot numbers.

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Link to this recall

<a href="https://govinfonow.com/recall/71876-civco-needle-guide-bracket-recall-cover-leak-risk">Civco Needle Guide Bracket Recall: Cover Leak Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2888-2018 (February 23, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2888-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.