FDA Medical Device Recalls (openFDA)
Sheathing Technologies Inc: 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
- Recall number
- Z-1006-2026
- Recalling firm
- Sheathing Technologies Inc
- Product
- 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,
- Status
- Open, Classified
- Initiated
- 2025-11-17
- Posted
- 2025-12-31
- Terminated
- not on file
- Reason
- Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
- Root cause
- Process control
- 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 Gretcheno@sheathes.com
- Quantity
- 12
- Distribution
- US Nationwide distribution in the state of WA.
- Lot, serial or model codes
- UDI-DI: 10842418100975. Lot Number: 25-45. Expiration Date: 2028-11-01
- 510(k) numbers
- K153212
- PMA numbers
- not on file
- Product code
- ITX
- Firm FEI
- 1000135740
- Firm city
- Morgan Hill
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28