FDA Medical Device Recalls (openFDA)
Ultroid Technologies, Inc.: Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile Probes
- Recall number
- Z-0782-2017
- Recalling firm
- Ultroid Technologies, Inc.
- Product
- Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile Probes
- Status
- Terminated
- Initiated
- 2016-10-19
- Posted
- not on file
- Terminated
- 2019-12-11
- Reason
- 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
- 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
- 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
- Lot, serial or model codes
- ALL serial numbers and lot numbers sold since 2003.
- 510(k) numbers
- ["K023706","K030315"]
- PMA numbers
- not on file
- Product code
- KNS
- Firm FEI
- 3013037032
- Firm city
- Tampa
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28