Ultrasound Transducer Probe Covers Recalled for Missing FDA Clearance
Exact Medical Manufacturing is recalling ultrasound transducer probe covers due to lack of FDA 510(k) clearance for use in natural or surgical body openings. The covers were distributed across six U.S. states 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 risk-of-harm product intended for use in natural or surgical body openings but lacking required FDA 510(k) clearance. While no illnesses or injuries have been reported, the absence of premarket clearance for an invasive medical device application represents a potential safety and effectiveness concern that cannot be verified.
Plain-English summary
Exact Medical Manufacturing is recalling approximately 9,680 units of 6-inch by 48-inch Elastic Poly Probe Covers (Item ID: A-AU-10-058N) used with ultrasonic transducers.
The product was marketed for use in natural or surgical body openings, but the manufacturer did not obtain the required FDA 510(k) premarket clearance before making this use claim. Using medical devices without proper FDA clearance raises concerns about safety and effectiveness that cannot be verified without the clearance review.
The affected probe covers were distributed to healthcare facilities in Florida, Montana, New York, Ohio, Georgia, and Puerto Rico. The recalled lots are: 1912E127, 2003E794, 2002E132, 2003E801, 2004E024, 2004E514, 2009E127, 2008E357, 2009E467, 2009E250, 2011E108, 2012E100, and 2012E104.
Healthcare facilities and any individuals who have these probe covers should stop using them for the stated purpose and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- 6" x 48" Elastic Poly Probe Cover, Tele Fold, sq. end,2 band - Ultrasonic Transducer Cover Item ID: A-AU-10- 058N
- Manufacturer
- Exact Medical Manufacturing, Inc.
- Hazard
- missing-510k-clearance
- invasive-use
Distribution
Distributed in 5 states:
- FL
- GA
- MT
- NY
- OH
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