Ultrasonic Transducer Probe Cover Recall: Missing FDA 510(k) Clearance
Exact Medical Manufacturing is recalling 1,600 ultrasonic probe covers distributed without FDA 510(k) clearance for use in body cavities and surgical openings. Users should discontinue use immediately.
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 an FDA Class II recall of a medical device intended for use in natural or surgical body openings that lacks required 510(k) premarket clearance. Although no injuries have been reported, the regulatory violation combined with the intended use on or in body cavities constitutes a risk-of-harm scenario qualifying for High severity under the rubric.
Plain-English summary
Exact Medical Manufacturing, Inc. is recalling 1,600 units of Probe Cover 6" x 96" (Item ID: A-AU-0778NA), a polyethylene ultrasonic transducer cover with 3 elastic bands. The affected lot numbers are 1908E209, 1908E435, 2005E171, and 2007E030.
The recalled product was distributed without FDA 510(k) premarket clearance for intended use in natural or surgical body openings. Medical devices intended for such use must receive FDA premarket review and clearance before distribution in the United States.
The affected units were distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.
Consumers and healthcare facilities currently using these probe covers should discontinue use immediately. Contact Exact Medical Manufacturing, Inc. for instructions on product return or replacement with FDA-cleared alternatives.
The recalled product
- Product
- Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Cover Item ID: A-AU-0778NA
- Manufacturer
- Exact Medical Manufacturing, Inc.
- Hazard
- regulatory-non-compliance
- uncleared-medical-device
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: 1908E209 1908E435 2005E171 2007E030
Distribution
Distributed in 5 states:
- FL
- GA
- MT
- NY
- OH
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