CLASS II Device recall · Reported 28 Dec 2016 · FDA Enforcement Report

Ultroid Hemorrhoid Management Systems 110/220 VAC recalled

Ultroid Technologies is recalling Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the, distributed in 34 states. The recall was initiated on 19 Oct 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesALL serial numbers and lot numbers sold since 2003.

Quantity recalled1,129

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-0782-2017
FDA event ID: 75055
Recalling firm: Ultroid Technologies, Tampa, FL
Classification: Class II
Status: Terminated
Recall initiated: 19 Oct 2016
FDA classified: 17 Dec 2016
Reported: 28 Dec 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

19 Oct 2016	Recall initiated by company
17 Dec 2016	Classified by FDA	+59 days
28 Dec 2016	Published in enforcement report	+11 days

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

Reason for recall

Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidance (such as 21 CFR 820 Quality System Regulation)

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

Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile Probes

Where it was distributed

AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, KS, LA, MD, ME, MI, MN, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA and Puerto Rico Asturias, Australia, Chile, Greece, Hong Kong, India, Indonesia, Iraq, Japan, Kuwait, Malaysia, Mexico, Nigeria, Qatar, Russia, Slovenia, Spain, Syria, Trinidad, Turkey, UAE, UK, and Vietnam

Alabama Arkansas Arizona California Colorado Connecticut Delaware Florida Georgia Idaho Illinois Kansas Louisiana Maryland Maine Michigan Minnesota Nebraska New Hampshire New Jersey

Questions about this recall

Is Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the recalled?

Yes. Ultroid Technologies recalled Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the on 19 Oct 2016. The recall is Class II and its status is Terminated. Recall number Z-0782-2017.

Why was it recalled?

Which lots are affected?

ALL serial numbers and lot numbers sold since 2003.

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 Ultroid Technologies

All 4

Reported	Class	Recall	Company	Reason	Where
28 Dec 2016Device	CLASS II	Ultroid Sterile Disposable Probes sold individually recalled	Ultroid Technologies	Sterility	34 states
28 Dec 2016Device	CLASS II	Ultroid Mobile Generator/Battery operated unit including recalled	Ultroid Technologies	Sterility	34 states
28 Dec 2016Device	CLASS II	Ultroid Procedure Pack including the Ultroid Sterile recalled	Ultroid Technologies	Sterility	34 states

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16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
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