Ultroid Mobile Generator and Sterile Probes Recalled for Quality System Failures
Ultroid Technologies is recalling 62 mobile generator units and sterile 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 hospitalizations. The hazard is a quality system failure without reported harm, fitting the Moderate category for low-risk or theoretical hazards.
Plain-English summary
Ultroid Technologies, Inc. is recalling 62 units of the Ultroid Mobile Generator/Battery operated unit, including the Ultroid Sterile Disposable Probes. The recall covers all serial numbers and lot numbers sold since January 14, 2003.
The recall was initiated 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 affected products were distributed in 33 U.S. states and Puerto Rico, as well as in numerous international locations including Australia, the UK, and Japan. Consumers and healthcare providers should stop using the affected units and contact the recalling firm for instructions.
The recalled product
- Product
- Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile Disposable Probes
- Manufacturer
- Ultroid Technologies, Inc.
- Affected units
- 62
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
Same manufacturer · Ultroid Technologies, Inc.
See all →- ModerateUltroid Sterile Disposable Probes Recalled for Quality System Non-Compliance
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- HighUltroid Procedure Pack Recalled for Quality System Non-Compliance
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