Ultroid Sterile Disposable Probes Recalled for Quality System Non-Compliance
Ultroid Technologies is recalling 7,784 sterile disposable probes because they were not manufactured under required quality system controls.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or deaths, and the hazard is related to quality system non-compliance rather than a specific high-risk pathogen or structural defect causing harm.
Plain-English summary
Ultroid Technologies, Inc. is recalling 7,784 units of Ultroid Sterile Disposable Probes sold individually. 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, directives, standards, and guidance, including the 21 CFR 820 Quality System Regulation. The source text does not report any specific illnesses, injuries, or deaths associated with these devices.
The affected products were distributed to 33 U.S. states, Puerto Rico, and 25 international countries. Consumers and healthcare facilities should stop using these probes and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Ultroid Sterile Disposable Probes sold individually
- Manufacturer
- Ultroid Technologies, Inc.
- Affected units
- 7,784
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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