Medical Probe Cover Recalled Due to Missing FDA Premarket Clearance
Exact Medical Manufacturing recalls 78,000 probe covers that lacked FDA premarket clearance. The product was distributed for use in body openings without required 510(k) approval.
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 for a device intended for insertion into body openings but lacking required premarket regulatory clearance. No illnesses or injuries have been reported, classifying it as a risk-of-harm product where injury has not yet occurred.
Plain-English summary
Exact Medical Manufacturing, Inc. is recalling 78,000 probe covers (Item ID SH17, 6" x 48" with hole) distributed in Florida, Montana, New York, Ohio, Georgia, and Puerto Rico. The affected lot numbers are 1909E197, 1910E296, 1911E050, 2002E180, and 2004E028.
The product was designed for use in natural or surgical body openings but lacks the FDA 510(k) premarket notification clearance required for such devices. This means the product was distributed without the necessary regulatory approval to confirm its safety and effectiveness for this use.
No illnesses or injuries have been reported. Consumers who have received this product should stop using it and contact their healthcare provider about alternative options.
The recalled product
- Product
- Probe Cover, PU and Elastic Blue Bands - 6" x 48", with hole Item ID: SH17
- Manufacturer
- Exact Medical Manufacturing, Inc.
- Hazard
- missing-510k
- 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: 1909E197 1910E296 1911E050 2002E180 2004E028
Distribution
Distributed in 5 states:
- FL
- GA
- MT
- NY
- OH
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