Elastic Poly Probe Cover lacks required FDA 510k clearance
Exact Medical Manufacturing is recalling 17,545 units of a 6" x 48" Elastic Poly Probe Cover that lacks FDA 510(k) clearance for use in body openings. The product should not be used without proper FDA pre-market approval.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II regulatory compliance recall with no reported injuries or illnesses. The issue is missing FDA pre-market clearance (510k approval), not an identified product defect or safety hazard.
Plain-English summary
Exact Medical Manufacturing, Inc. is recalling 17,545 units of its 6" x 48" Elastic Poly Probe Cover (Item ID: A-AU-0852NA, Lot Numbers: 1912E126, 2002E133, 2008E227, 2008E226) distributed in Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.
The product is being recalled because it lacks the required FDA 510(k) pre-market notification clearance. Class II medical devices intended for use in natural or surgical body openings must receive FDA 510(k) clearance before distribution in the United States.
Healthcare facilities and patients who have this product should cease use immediately. Contact Exact Medical Manufacturing, Inc. for instructions on returning or replacing the product. Questions should be directed to the manufacturer or your healthcare provider.
The recalled product
- Product
- 6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852NA
- Manufacturer
- Exact Medical Manufacturing, Inc.
- Hazard
- unapproved-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: 1912E126 2002E133 2008E227 2008E226
Distribution
Distributed in 5 states:
- FL
- GA
- MT
- NY
- OH
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