Ultrasonic Transducer Covers Lack FDA Clearance for Body Cavity Use
Exact Medical Manufacturing is recalling 7,920 ultrasonic transducer probe covers distributed across six states and Puerto Rico because they lack required FDA 510(k) clearance for use in body cavities and surgical openings.
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: FDA Class II recall involving a medical device intended for body cavity use but lacking required 510(k) premarket clearance. No illnesses or injuries are reported in the source text, so the hazard is regulatory/approval-based rather than documented clinical harm. Per the rubric, Class II without reported injuries scores at most 3.
Plain-English summary
Exact Medical Manufacturing, Inc. is recalling 7,920 units of 6" × 96" Elastic Poly Probe Covers (Item ID: A-AU-0853NA) intended for use as ultrasonic transducer covers. The affected product was distributed to healthcare facilities in Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.
The recall was initiated because the product was marketed without obtaining the required FDA 510(k) premarket notification clearance. This authorization is mandatory before a medical device can be marketed for use in body cavities or in direct contact with surgical openings. Without this clearance, the device lacks documented evidence of safety and effectiveness for its intended use.
Affected lot numbers are: 1907E386, 1911E049, 1911E047, 1911E261, 1912E129, 1912E128, 2003E604, 2003E633, 2003E240, 2003E932, 2003E931, 2005E439, 2007E257, 2010E215, 2012E099, 2012E506, and 2101E071.
Healthcare facilities using these covers should discontinue use immediately. Adverse events or injuries associated with use of this product should be reported to the FDA.
The recalled product
- Product
- 6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Transducer Cover Item ID: A-AU- 0853NA
- Manufacturer
- Exact Medical Manufacturing, Inc.
- Hazard
- regulatory-non-compliance
- missing-510k-clearance
- uncleared-device
Distribution
Distributed in 5 states:
- FL
- GA
- MT
- NY
- OH
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