FDA Recalls Ultroid Hemorrhoid Management Systems for Quality System Deficiencies
The FDA is recalling Ultroid Hemorrhoid Management Systems because they were not manufactured under required quality system controls.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II, which corresponds to a 'Severe' severity score under the rubric for medical devices.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling the Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit, including the Ultroid Disposable Sterile Probes. The recall was initiated by Ultroid Technologies, Inc. because the products were 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 the 21 CFR 820 Quality System Regulation.
The recall affects 1,129 units. The products were distributed to 32 U.S. states and Puerto Rico, as well as 24 international locations including Australia, Japan, and the United Kingdom. The recall covers all serial numbers and lot numbers sold since 2003.
The FDA has classified this recall as Class II. Consumers and healthcare providers should stop using the affected products and contact the manufacturer for further instructions.
The recalled product
- Product
- Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile Probes
- Manufacturer
- Ultroid Technologies, Inc.
- Affected units
- 1,129
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- ALL serial numbers and lot numbers sold since 2003.
Distribution
Part of a larger recall action
This product is one of 4 recalled by Ultroid Technologies, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Ultroid Technologies, Inc.
See all →- ModerateUltroid Sterile Disposable Probes Recalled for Quality System Non-Compliance
FDA (Devices) · 2016-12-28
- ModerateUltroid Mobile Generator and Sterile Probes Recalled for Quality System Failures
FDA (Devices) · 2016-12-28
- HighUltroid Procedure Pack Recalled for Quality System Non-Compliance
FDA (Devices) · 2016-12-28
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