Ultrasonic Transducer Probe Covers Recalled for Missing FDA Clearance
Exact Medical Manufacturing is recalling 33,250 ultrasonic transducer probe covers lacking required FDA 510(k) clearance for use in natural or surgical body openings, distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.
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: This is a Class II medical device recall involving a product marketed without required FDA 510(k) clearance for use in natural or surgical body openings. While no injuries or illnesses have been reported, the lack of regulatory clearance for the intended use represents a risk-of-harm product where proper safety evaluation has not been completed.
Plain-English summary
Exact Medical Manufacturing, Inc. is recalling 33,250 units of the Probe Cover - 6" x 3" x 96" Ultrasonic Transducer Cover (Item ID: SH22). The recalled units were distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.
The product was manufactured without the required FDA 510(k) pre-market notification clearance for use in natural or surgical openings of the body. Medical devices intended for such use must obtain FDA review and approval before being marketed. The affected lot numbers are: 2008E475, 2009E247, 2010E217, 2012E102, and 2012E191.
Those who have received these probe covers should not use them for any application involving natural or surgical body openings.
The recalled product
- Product
- Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22
- Manufacturer
- Exact Medical Manufacturing, Inc.
- Hazard
- medical-device-unapproved
- unauthorized-use
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: 2008E475 2009E247 2010E217 2012E102 2012E191
Distribution
Distributed in 5 states:
- FL
- GA
- MT
- NY
- OH
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