Sheathes3D recallZ-1006-2026 · Sheathing Technologies Inc · initiated Nov 17, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Sheathing Technologies Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Process control
What the company is doing
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]
Recall details
- Recall number
- Z-1006-2026
- Status
- Open, Classified
- Initiated by the company
- Nov 17, 2025
- Posted by the FDA
- Dec 31, 2025
- Recalling firm
- Sheathing Technologies Inc
- Quantity
- 12
- Product code
- ITX
- FDA submissions
- K153212
- Distribution
- US Nationwide distribution in the state of WA.
Product description
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,
Code information (models, lots, serial numbers)
UDI-DI: 10842418100975. Lot Number: 25-45. Expiration Date: 2028-11-01
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Sheathes3D 76339Sheathing Technologies, Inc. · Transducer, Ultrasonic, Diagnostic1 recall0 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K153212 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Sheathes3D ADH-35-4Sheathing Technologies, Inc. · Transducer, Ultrasonic, Diagnostic1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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