Z-0782-2017Class II

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

Name: Z-0782-2017 Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile...
Creator: Ultroid Technologies, Inc.
Published: 2016-10-19
License: https://open.fda.gov/license/

Hudson Scientific LLC / initiated 2016-10-19 / Terminated / root cause: manufacturing process

FDA source

Ultroid Technologies, Inc. began a recall of Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile Probes on 2016-10-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0782-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-19
Posted: 2016-12-17
Terminated: 2019-12-11
Recalling firm: Hudson Scientific LLC
Product: Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile Probes
Product code: KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
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)
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On October 19, 2016 Ultrid sent a recall letter to all their consignees informing them of the recall and to cease further distribution of this product, respond the self-addressed response form and returned for a voucher. For more information contact Melanie Rosario at 727-898-0717
Quantity in commerce: 1,129
Distribution: 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
Product codes and lots: ALL serial numbers and lot numbers sold since 2003.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0782-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0782-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-17
Z-0783-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-17
Z-0784-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-17
Z-0785-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-17

Product code KNS

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)