Quick Facts at a Glance
- Recall Date
- November 17, 2025
- Hazard Level
- HIGH
- Brand
- Sheathing Technologies
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Sheathing Technologies
- Product type
- Ultrasound Probe Cover
- Model numbers
- UDI-DI: 10842418100975, Lot Number: 25-45, Expiration Date: 2028-11-01
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 17, 2025
Reported by FDA DEVICE
January 7, 2026
RecallRadar source check
January 14, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
What You Should Do
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
About This Product
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.
Why This Is Dangerous
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.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
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.
Practical Guidance
How to identify if yours is affected
- Check the packaging for the lot number 25-45.
- Look for the UDI-DI number 10842418100975 on the box.
- Verify the expiration date listed as November 1, 2028.
Where to find product info
The lot number and UDI-DI can typically be found on the box or packaging of the ultrasound probe covers.
What timeline to expect
Expect a response from the manufacturer regarding refunds or instructions within 4-6 weeks.
If the manufacturer is unresponsive
- Contact Sheathing Technologies Inc again for further assistance.
- Document all communications for your records.
- Consider reaching out to the FDA if issues persist.
How to prevent similar issues
- Always verify if medical devices have been recalled before using them.
- Choose products with FDA approval and good reviews.
- Purchase from reputable medical supply companies.
Documentation advice
Keep records of your purchase, including receipts and any correspondence with the manufacturer regarding the recall.
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Product Details
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.
Key Facts
- Recall date: November 17, 2025
- Class II recall
- Expiration date: November 1, 2028
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