Ultrasonic Probe Covers Lack FDA Clearance for Body Use
Exact Medical Manufacturing recalls ultrasonic transducer probe covers marketed without required FDA 510(k) clearance for use in body openings. Approximately 129,600 units distributed to FL, MT, NY, OH, GA, and Puerto Rico.
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 recall of a medical device marketed without required 510(k) clearance for use in body openings. No reported illnesses or injuries have been documented, making this a risk-of-harm scenario with regulatory non-compliance.
Plain-English summary
Exact Medical Manufacturing, Inc. is recalling Probe Cover Elastic Poly 6" x 48" ultrasonic transducer covers (Item ID: E5322N) due to regulatory non-compliance.
The recalled product was marketed and distributed for use in natural or surgical body openings without the required FDA 510(k) premarket notification clearance. This clearance is required before medical devices can be legally marketed for such uses in the United States.
Approximately 129,600 units were distributed to healthcare facilities in Florida, Montana, New York, Ohio, Georgia, and Puerto Rico, spanning 11 lot numbers from the manufacturing dates specified in the recall notice.
Healthcare providers who have used or possess units from the affected lot numbers should discontinue use and contact Exact Medical Manufacturing for return or replacement instructions.
The recalled product
- Product
- Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N
- Manufacturer
- Exact Medical Manufacturing, Inc.
- Affected units
- 129,600
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
- ModerateUltrasonic Transducer Probe Covers Recalled Due to Missing FDA Clearance
FDA (Devices) · 2021-06-30
- HighTransducer Covers Recalled for Missing FDA 510(k) Clearance
FDA (Devices) · 2021-06-30