Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Probe Cover Recalled by Exact Medical Manufacturing, Inc. Due to No 510k for the product to be used...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Exact Medical Manufacturing, Inc. directly.
Affected Products
Probe Cover, 6"x96" poly, tapered end, w 3 bands-Ultrasonic Transducer Cover Item ID: A-AU-0980N
Quantity: 12650 units
Why Was This Recalled?
No 510k for the product to be used in a natural or surgical opening to the body
Where Was This Sold?
This product was distributed to 5 states: FL, GA, MT, NY, OH
About Exact Medical Manufacturing, Inc.
Exact Medical Manufacturing, Inc. has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report