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U.S. Department of Health and Human Services

Class 2 Device Recall Sheathes3D" Seamless Viral Barrier, LatexFree

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 Class 2 Device Recall Sheathes3D" Seamless Viral Barrier, LatexFreesee related information
Date Initiated by FirmNovember 17, 2025
Date PostedDecember 31, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1006-2026
Recall Event ID 98068
510(K)NumberK153212 
Product Classification Transducer, ultrasonic, diagnostic - Product Code ITX
ProductSheathes3D 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,
Code Information UDI-DI: 10842418100975. Lot Number: 25-45. Expiration Date: 2028-11-01
FEI Number 1000135740
Recalling Firm/
Manufacturer		 Sheathing Technologies Inc
675 Jarvis Dr
Morgan Hill CA 95037-2815
For Additional Information ContactSamantha Polayes
408-782-2720
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionOn 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 Gretcheno@sheathes.com
Quantity in Commerce12
DistributionUS Nationwide distribution in the state of WA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = ITX
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