Unrated Medical device recall · FDA · Published November 2, 2018

Civco SonoSite Needle Guide Bracket Recall: Risk of Injury from Improper Use

Civco Medical Instruments recalls SonoSite FUJIFILM Needle Guide Brackets with lot numbers A000012-A050663. These reusable brackets may cause injury if not used properly with SonoSite L25 transducers.

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

🇺🇸 FDA recall #Z-0567-2019Medical device Civco Medical Instruments ›

Recall notice

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Contact the company

Recalling firmCIVCO Medical Instruments Co., Inc.2301 Jones Blvd · Coralville, IA 52241-3469

✎ GovInfoNow plain-language explainer

Civco Medical Instruments is recalling SonoSite FUJIFILM Needle Guide Brackets (REF P06013-08) that may cause injury if not used correctly with SonoSite L25 transducers. This recall affects brackets sold with specific lot numbers and inventory without proper labeling. Read more at govinfonow.com/recall/69503-civco-sonosite-needle-guide-bracket-recall-risk-of-injury-from.

Source Summary by GovInfoNow · govinfonow.com/recall/69503-civco-sonosite-needle-guide-bracket-recall-risk-of-injury-from · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0567-2019

Cite this page

“Civco SonoSite Needle Guide Bracket Recall: Risk of Injury from Improper Use.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69503-civco-sonosite-needle-guide-bracket-recall-risk-of-injury-from. Based on FDA recall #Z-0567-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0567-2019%22&limit=1).

The FDA announced on 2018-11-02 that Civco Medical Instruments Co., Inc. voluntarily recalled the SonoSite FUJIFILM Needle Guide Bracket, REF number P06013-08. The recall affects reusable non-sterile brackets for use with SonoSite L25 series transducers distributed internationally.

How to tell if you have it

Brand: Civco Medical Instruments
Product: SonoSite FUJIFILM Needle Guide Bracket, REF number P06013-08
Lot numbers: A000012-A050663, M000880-M995980, and P022503
All brackets in inventory that no longer have the product labeling

Context

GovInfoNow's records show Civco Medical Instruments Co. Inc. has 5 other recalls on record since 2018-02-23. Other recent recalls of similar products include Olympus HX-400U-30 Ligating Device Recall (2025-10-30), Olympus Single Use Sphincterotome V Recall (2026-01-07), and Merit Medical Splashwire Hydrophilic Guide Wire Recall (2026-05-08).

How to tell if you have this one

Check for lot numbers on the bracket between A000012 and A050663. Also look for brackets without product labeling or those in inventory that no longer have the required labeling.

Brand
Civco Medical Instruments
Category
Medical device

FDA recall event · 15 products

All 15 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Foreign distribution was made to Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Croatia, Cyprus, Denmark, Estonia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Trinidad/Tobago, Turkey, Ukraine, United Arab Emirates, and the United Kingdom.

Recall number	Product, codes & lots	Quantity
Z-0562-2019	CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable non-sterile single-angle bracket for use with SonoSite L25 series tranducers, RX. The firm name on the label is CIVCO, Kalona, IA.; Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.	738 boxes
Z-0563-2019	SonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracket, REF numbers P03122-01, P03122-02, P03122-03, P03122-04, and P03122-05, Mfg for: SonoSite, Inc., Bothell, WA.; Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.	1,375 boxes
Z-0564-2019	CIVCO Needle Guide Bracket, REF P03122-06, Reusable non-sterile bracket for use with SonoSite L25/L25e transducers, Mfg by: CIVCO, Kalona, IA.; Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.	948 boxes
Z-0565-2019	CIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracket for use with SonoSite L25 series transducers.; Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.	73 boxes
Z-0566-2019	SonoSite Needle Guide Bracket, REF numbers P06013-06 and P06013-07, Reusable non-sterile bracket for use with SonoSite L25 series transducers.; Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.	297 boxes
Z-0567-2019	SonoSite FUJIFILM Needle Guide Bracket, REF number P06013-08, Reusable non-sterile bracket for use with SonoSite L25 series transducers. Mfg for:; Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.	115 boxes
Z-0568-2019	CIVCO Needle Guide Starter Kit, REF numbers P12920-01 and P12920-02, Reusable non-sterile bracket with sterile (1.5cm, 2.5cm, 3.5cm, 4.5cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers ((5) for use with SonoSite L25 series transducers, 18 GAUGE, Rx.; Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.	257 boxes
Z-0569-2019	CIVCO Needle Guide Starter Kit, REF numbers P12922-01 and P12922-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers (5) for use with SonoSite L25 series transducers, 21 GAUGE, Rx.; Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.	234 boxes
Z-0570-2019	CIVCO Needle Guide Starter Kit, REF numbers P12924-01 and P12924-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers (5) for use with SonoSite L25 series transducers, 22 GAUGE, Rx.; Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.	66 boxes
Z-0571-2019	CIVCO Needle Guide Starter Kit, REF 674-037, Reusable non-sterile bracket with sterile needle guides (1.5cm, 2.5cm, 3.5cm, 4.5 depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 18 GAUGE, Rx.; Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.	468 boxes
Z-0572-2019	CIVCO Needle Guide Starter Kit, REF 674-038, Reusable non-sterile bracket with sterile needle guide (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 21 GAUGE, Rx. The firm name on the label is CIVCO, Kalona, IA..; Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.	613 boxes
Z-0573-2019	CIVCO Needle Guide Starter Kit, REF 674-039, Reusable non-sterile bracket with sterile needle guides (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 22 GAUGE, Rx.; Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.	20 boxes
Z-0574-2019	CIVCO Needle Guide Bracket, REF 674-057, Reusable non-sterile bracket for use with SonoSite L25 series tranducers, Rx.; Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.	49 boxes
Z-0575-2019	CIVCO Needle Guide Bracket, REF 674-057-10, Reusable non-sterile bracket for use with FUJIFILM SonoSite, Inc. L25 series tranducers, Rx.; Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.	3 boxes
Z-0576-2019	CIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales representatives.; Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.	135 boxes

Based on the official FDA remedy

What to do — step by step

Check Product Labeling
Verify the bracket has current product labeling with the correct lot number range.
Stop Using if Unlabeled
Discontinue use immediately if the bracket lacks product labeling.

How this recall unfolded

Recall timeline

FDA terminated this recall 2.1 years after the firm started it.

Nov 2, 2018Firm started the recall
Dec 7, 2018FDA classified it Class II
Dec 19, 2018Published in FDA’s Enforcement Report
Nov 20, 2020FDA terminated the recall

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

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Link to this recall

<a href="https://govinfonow.com/recall/69503-civco-sonosite-needle-guide-bracket-recall-risk-of-injury-from">Civco SonoSite Needle Guide Bracket Recall: Risk of Injury from Improper Use (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-0567-2019 (November 2, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0567-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.