Ultrasound probe covers recalled for missing required FDA 510k clearance
Exact Medical Manufacturing is recalling 800 units of ultrasound probe covers distributed to six states and Puerto Rico because they lack required FDA 510(k) clearance for use in natural or surgical body openings.
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: FDA Class II with no reported illnesses or injuries. The product is an uncleared medical device marketed for use in body openings without required 510(k) clearance, constituting a risk-of-harm scenario per the severity rubric.
Plain-English summary
Exact Medical Manufacturing, Inc. is recalling 800 units of Probe Cover, PE, Elastic Bands (Item ID: 1006576) distributed across Florida, Montana, New York, Ohio, Georgia, and Puerto Rico. The affected lot numbers are 1909E198, 1911E260, and 2011E248.
The recall was issued because the product was distributed without the required FDA 510(k) premarket clearance for use in natural or surgical body openings. This means the device was marketed for a use that requires FDA review and approval, but such clearance was not obtained prior to distribution.
Healthcare facilities and users who possess affected units should discontinue use. Consult with Exact Medical Manufacturing or the FDA for guidance on product disposition and any necessary replacement options.
The recalled product
- Product
- Probe Cover, PE, Elastic Bands, 15x244cm-6"x96" -Ultrasonic Transducer Cover Item ID: 1006576
- Manufacturer
- Exact Medical Manufacturing, Inc.
- Hazard
- uncleared-device
- regulatory-non-compliance
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: 1909E198 1911E260 2011E248
Distribution
Distributed in 5 states:
- FL
- GA
- MT
- NY
- OH
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