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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Sheathes3D Ultrasound Probe Covers Recalled for Viral Barrier Defects

Agency Publication Date: December 31, 2025
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Summary

Sheathing Technologies Inc is recalling 12 boxes of Sheathes3D Seamless Viral Barrier ultrasound probe covers used for vaginal and rectal examinations. These latex-free, non-sterile covers may have product defects that compromise their viral barrier, potentially leading to contamination during medical procedures. The affected items are individually wrapped in boxes of 50 and were distributed specifically in Washington state.

Risk

Defects in the protective viral barrier could allow for cross-contamination between the ultrasound probe and the patient. This poses a risk of infection during diagnostic imaging procedures.

What You Should Do

  1. This recall involves Sheathes3D Seamless Viral Barrier, Latex-Free, Tapered Ultrasound Probe Covers (Item Number 76339) from Lot Number 25-45 with an expiration date of 2028-11-01.
  2. Check the labeling on the box of 50 individually wrapped covers to identify the lot number and the UDI-DI code 10842418100975.
  3. Stop using the recalled product. Contact Sheathing Technologies Inc or your medical supply distributor to arrange for the return, replacement, or correction of the defective probe covers.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for more information regarding this device recall.

Your Remedy Options

๐Ÿ“‹Other Action

The firm initiated the recall via a notification letter.

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Sheathes3D Seamless Viral Barrier Ultrasound Probe Cover (Box of 50)
Variants: Latex-Free, Non-Sterile, Vaginal/Rectal, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm Tapered to 7.4cm x 30cm), Tapered, Rolled, Extra-Long, Individually Wrapped
Model / REF:
76339
Lot Numbers:
25-45 (Exp 2028-11-01)
UDI:
10842418100975

Recall Number: Z-1006-2026. Distributed in Washington state.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98068
Status: Active
Manufacturer: Sheathing Technologies Inc
Sold By: Medical supply distributors
Manufactured In: United States
Units Affected: 12
Distributed To: Washington

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.