Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm Tapered to 7.4cm x 30cm), Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled, Extra-Long, Individually Wrapped, Box of 50 Item Number 76339,
FDA Recall Z-1006-2026 · Posted 2025-12-31
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Recalling FirmSheathing Technologies Inc
Recall StatusOpen, Classified
Product CodeITX
Date Initiated2025-11-17
Product Quantity12
Reason for Recall
Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
Firm Action
On 11/17/2025, recall notices were emailed to customers asked to do the following:
1) Quarantine products subject to recall.
2) This recall should be carried out to the user level.
3) Complete and return the response form via email to [email protected]
Root Cause
Process control
Distribution Pattern
US Nationwide distribution in the state of WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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