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

Civco Needle Guide Bracket recalled by CIVCO Medical Instruments Co

Civco Medical Instruments is recalling Civco 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 recalled738 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-0562-2019
FDA event ID: 81361
Recalling firm: Civco Medical Instruments, 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

The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.

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

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.

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

Why was it recalled?

The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.

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

Other products in this recall event

14 other products · FDA event 81361

This product is part of a recall event; the main page for the event is SonoSite Fujifilm Needle Guide Bracket recalled.

Reported	Class	Recall	Company	Reason	Where
19 Dec 2018	CLASS II	SonoSite Fujifilm Needle Guide Bracket recalled	Civco Medical Instruments	Other	IA
19 Dec 2018	CLASS II	Civco Sales Demo Kit recalled by CIVCO Medical Instruments Co	Civco Medical Instruments	Other	IA
19 Dec 2018	CLASS II	Civco Biopsy Bracket recalled by CIVCO Medical Instruments Co	Civco Medical Instruments	Other	IA
19 Dec 2018	CLASS II	SonoSite Needle Guide Bracket recalled by CIVCO Medical Instruments Co	Civco Medical Instruments	Other	IA
19 Dec 2018	CLASS II	Civco Needle Guide Bracket recalled by CIVCO Medical Instruments Co	Civco Medical Instruments	Other	IA
19 Dec 2018	CLASS II	Civco Needle Guide Starter Kit recalled by CIVCO Medical Instruments Co	Civco Medical Instruments	Other	IA
19 Dec 2018	CLASS II	Civco Needle Guide Starter Kit recalled by CIVCO Medical Instruments Co	Civco Medical Instruments	Other	IA
19 Dec 2018	CLASS II	SonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracket recalled	Civco Medical Instruments	Sterility	IA
19 Dec 2018	CLASS II	Civco Needle Guide Starter Kit recalled by CIVCO Medical Instruments Co	Civco Medical Instruments	Other	IA
19 Dec 2018	CLASS II	Civco Needle Guide Starter Kit recalled by CIVCO Medical Instruments Co	Civco Medical Instruments	Other	IA
19 Dec 2018	CLASS II	Civco Needle Guide Bracket recalled by CIVCO Medical Instruments Co	Civco Medical Instruments	Sterility	IA
19 Dec 2018	CLASS II	Civco Needle Guide Starter Kit recalled by CIVCO Medical Instruments Co	Civco Medical Instruments	Other	IA
19 Dec 2018	CLASS II	Civco Needle Guide Starter Kit recalled by CIVCO Medical Instruments Co	Civco Medical Instruments	Other	IA
19 Dec 2018	CLASS II	Civco Needle Guide Bracket recalled by CIVCO Medical Instruments Co	Civco Medical Instruments	Other	IA

More recalls from Civco Medical Instruments

All 45

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

Other Syringes & Needles recalls

All 1,066

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	Embosphere 500-700 micrometer Syringe Sterile Steam recalled	Merit Medical Systems	Sterility	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
23 Sep 2026Device	CLASS II	Medrad¿ Stellant Flex Syringe Kit used recalled by Bayer Medical Care	Bayer Medical Care	Sterility	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide