Ultroid Procedure Pack Recalled for Quality System Non-Compliance
Ultroid Technologies is recalling 52,084 procedure packs because they were not manufactured under required quality system controls.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls without specific hospitalization reports or structural defects fall into the High severity category, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Ultroid Technologies, Inc. is recalling 52,084 units of the Ultroid Procedure Pack, which includes Ultroid Sterile Disposable Probes. The recall covers all serial numbers and lot numbers sold since January 14, 2003.
The FDA classified this as a Class II recall because the products were not designed, qualified, manufactured, or managed under a state of control per internal quality system procedures and external laws, regulations, and standards, including the 21 CFR 820 Quality System Regulation.
The affected products were distributed across 33 U.S. states, Puerto Rico, and 24 international locations. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Ultroid Procedure Pack including the Ultroid Sterile Disposable Probes.
- Manufacturer
- Ultroid Technologies, Inc.
- Affected units
- 52,084
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 (2)
- ALL serial numbers and lot numbers sold since January 14
- 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
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- SevereFDA Recalls Ultroid Hemorrhoid Management Systems for Quality System Deficiencies
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