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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Affected units
- 1,600
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
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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