Sheathing Technologies recalled 12 units of its ultrasound probe covers on November 17, 2025, due to potential contamination risks. The non-sterile vaginal and rectal covers may have defects that pose an infection risk during use. Consumers should stop using the product immediately and follow the manufacturer's instructions.
Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Sheathing Technologies Inc or your healthcare provider for instructions. Notification method: Letter
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The Sheathes3D Seamless Viral Barrier is designed for use in medical examinations requiring ultrasound procedures. These covers provide a protective layer during vaginal and rectal examinations, ensuring safety and hygiene.
The defects in the probe covers may allow for contamination, which could lead to infections during medical procedures. This contamination risk is particularly concerning during intimate examinations.
This recall is not part of a broader industry pattern.
The recall highlights the importance of using safe medical devices, especially in sensitive procedures. Patients and healthcare providers must ensure they do not use the affected products to avoid potential health risks.
The lot number and UDI-DI can typically be found on the box or packaging of the ultrasound probe covers.
Expect a response from the manufacturer regarding refunds or instructions within 4-6 weeks.
Keep records of your purchase, including receipts and any correspondence with the manufacturer regarding the recall.
The recalled product is the Sheathes3D Seamless Viral Barrier, a latex-free ultrasound probe cover, measuring 7/8"D tapered to 2.9"W x 11.8"L. The product is sold in a box of 50 under item number 76339, with a UDI-DI of 10842418100975. The lot number is 25-45 and it expires on November 1, 2028.
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