CLASS II Device recall · Reported 19 Dec 2018 · FDA Enforcement Report

SonoSite Needle Guide Bracket recalled by CIVCO Medical Instruments Co

CIVCO Medical Instruments Co is recalling SonoSite Needle Guide Bracket. The recall was initiated on 2 Nov 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBoxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Quantity recalled297 boxes

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0566-2019
FDA event ID: 81361
Recalling firm: CIVCO Medical Instruments Co, Coralville, IA
Classification: Class II
Status: Terminated
Recall initiated: 2 Nov 2018
FDA classified: 7 Dec 2018
Reported: 19 Dec 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Syringes & Needles

Timeline

2 Nov 2018	Recall initiated by company
7 Dec 2018	Classified by FDA	+35 days
19 Dec 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Not stated in the enforcement report.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

SonoSite Needle Guide Bracket, REF numbers P06013-06 and P06013-07, Reusable non-sterile bracket for use with SonoSite L25 series transducers.

Where it was distributed

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.

Questions about this recall

Is SonoSite Needle Guide Bracket recalled?

Yes. CIVCO Medical Instruments Co recalled SonoSite Needle Guide Bracket on 2 Nov 2018. The recall is Class II and its status is Terminated. Recall number Z-0566-2019.

Why was it recalled?

The reason has not been published.

Which lots are affected?

Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from CIVCO Medical Instruments Co

All 36

Reported	Class	Recall	Company	Reason	Where
8 Apr 2026Device	CLASS II	eTRAX Needle System Starter Kit (for Aurora Trackers) recalled	Civco Medical Instruments Co	Processing Deviation	OH, PA, WA
8 Apr 2026Device	CLASS II	eTRAX Needle Sensor -(for Aurora Trackers) recalled	Civco Medical Instruments Co	Processing Deviation	OH, PA, WA
8 Apr 2026Device	CLASS II	eTRAX Needle Sensor - (for Aurora Trackers) recalled	Civco Medical Instruments Co	Processing Deviation	OH, PA, WA
8 Apr 2026Device	CLASS II	eTRAX Needle System Starter Kit (for Aurora Trackers) recalled	Civco Medical Instruments Co	Processing Deviation	OH, PA, WA
8 Apr 2026Device	CLASS II	eTRAX Needle Sensor -(for Aurora Trackers) recalled	Civco Medical Instruments Co	Processing Deviation	OH, PA, WA

Other Syringes & Needles recalls

All 1,060

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS I	BD Needle Kit for Powered Driver recalled by Bard Access Systems	Bard Access Systems	Other	32 states
19 Aug 2026Device	CLASS II	Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled	Galt Medical	Other	Nationwide
15 Jul 2026Device	CLASS II	Geneva Brachytherapy Applicator recalled by Elekta	Elekta	Other	Nationwide
15 Jul 2026Device	CLASS II	Brachytherapy Applicator Advanced Gynecological Applicator recalled	Elekta	Other	Nationwide
8 Jul 2026Device	CLASS II	Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled	Bd Switzerland Sarl	Other	IL