Ultrasonic Transducer Probe Covers Recalled Due to Missing FDA Clearance
Exact Medical Manufacturing recalled 36,000 ultrasonic transducer probe covers due to missing FDA 510k premarket notification clearance. The affected units were distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.
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 2/5 (Moderate).
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 FDA Class II medical device recall involves marketing without required 510k premarket notification clearance. No injuries or illnesses have been reported, and the violation is regulatory rather than based on a known safety defect.
Plain-English summary
Exact Medical Manufacturing, Inc. has recalled 36,000 Probe Cover 6"x48" Ultrasonic Transducer Covers (Item ID: SH29) because they were marketed without required FDA 510k premarket notification clearance.
These probe covers are designed to be used with ultrasound transducers in contact with natural or surgical body openings. Under FDA regulations, medical devices intended for such use must receive 510k premarket notification clearance before distribution in the United States. The affected lot numbers are 1910E448, 2009E249, 2009E248, 2010E214, and 2011E249.
The recalled covers were distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico. A total of 36,000 units are subject to this recall.
The recalled product
- Product
- Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29
- Manufacturer
- Exact Medical Manufacturing, Inc.
- Hazard
- Affected units
- 36,000
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: 1910E448 2009E249 2009E248 2010E214 2011E249
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
Same manufacturer · Exact Medical Manufacturing, Inc.
See all →- ModerateUltrasonic Probe Covers Recalled for Missing FDA Clearance
FDA (Devices) · 2021-06-30
- ModerateUltrasonic Transducer Probe Cover Recalled for Lacking FDA Clearance
FDA (Devices) · 2021-06-30
- HighTransducer Cover Lacks FDA 510(k) Clearance for Surgical Use
FDA (Devices) · 2021-06-30
- HighUltrasound Probe Cover Kit Recalled for Lack of FDA Clearance
FDA (Devices) · 2021-06-30
- HighUltrasonic Transducer Probe Cover Recall: Missing FDA 510(k) Clearance
FDA (Devices) · 2021-06-30
Same hazard · missing 510k clearance
See all →- HighArrow Temporary Pacing Catheter Distributed Without FDA 510K Clearance
FDA (Devices) · 2021-07-21
- HighUltrasonic Transducer Covers Lack FDA Clearance for Body Cavity Use
FDA (Devices) · 2021-06-30
- HighUltrasound Transducer Probe Covers Recalled for Missing FDA Clearance
FDA (Devices) · 2021-06-30
- HighUltrasonic Probe Covers Lack FDA Clearance for Body Use
FDA (Devices) · 2021-06-30
- HighTransducer Covers Recalled for Missing FDA 510(k) Clearance
FDA (Devices) · 2021-06-30
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