Ultrasonic Transducer Probe Covers Recalled Due to Missing FDA Clearance
Exact Medical Manufacturing recalled 36,000 ultrasonic transducer probe covers due to missing FDA 510k premarket notification clearance. The affected units were distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.
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: This FDA Class II medical device recall involves marketing without required 510k premarket notification clearance. No injuries or illnesses have been reported, and the violation is regulatory rather than based on a known safety defect.
Plain-English summary
Exact Medical Manufacturing, Inc. has recalled 36,000 Probe Cover 6"x48" Ultrasonic Transducer Covers (Item ID: SH29) because they were marketed without required FDA 510k premarket notification clearance.
These probe covers are designed to be used with ultrasound transducers in contact with natural or surgical body openings. Under FDA regulations, medical devices intended for such use must receive 510k premarket notification clearance before distribution in the United States. The affected lot numbers are 1910E448, 2009E249, 2009E248, 2010E214, and 2011E249.
The recalled covers were distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico. A total of 36,000 units are subject to this recall.
The recalled product
- Product
- Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29
- Manufacturer
- Exact Medical Manufacturing, Inc.
- Hazard
- missing-510k-clearance
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)
- Lot Numbers: 1910E448 2009E249 2009E248 2010E214 2011E249
Distribution
Distributed in 5 states:
- FL
- GA
- MT
- NY
- OH
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