Ultrasonic Probe Cover Recalled for Missing FDA 510(k) Clearance
Exact Medical Manufacturing is recalling ultrasonic probe covers lacking required FDA 510(k) clearance for use in natural or surgical body openings. The 51,300 affected units 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 device intended for invasive use in natural or surgical body openings that was marketed without required FDA 510(k) clearance. Per the rubric, this qualifies as a risk-of-harm product where no injury has been reported, warranting a High severity classification.
Plain-English summary
Exact Medical Manufacturing, Inc. is recalling Probe Cover item E6443N (6" x 96" polyethylene with 3 elastic bands), an ultrasonic transducer cover. The product was marketed for use in natural or surgical body openings without the required FDA 510(k) clearance.
The 510(k) is the FDA's premarket notification required before a medical device can be legally marketed for a specific use. The product lacked this required clearance for its intended use.
The recall affects 51,300 units distributed to medical facilities in Florida, Montana, New York, Ohio, Georgia, and Puerto Rico. Affected lot numbers include: 1906E310, 1908E208, 1908E561, 1910E032, 1910E350, 1911E262, 1912E540, 2003E308, 2002E135, 2003E324, 2004E513, 2009E129, 2009E408, 2101E069, and 2011E404.
The recalled product
- Product
- Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N
- Manufacturer
- Exact Medical Manufacturing, Inc.
- Hazard
- Affected units
- 51,300
Distribution
Part of a larger recall action
This product is one of 18 recalled by Exact Medical Manufacturing, 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 18 products in this recall →Related recalls
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