Recall Z-1006-2026 ยท ITX Transducer, Ultrasonic, Diagnostic
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,
| Date | Dec 31, 2025 (initiated Nov 17, 2025) |
| Status | Open, Classified |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153212 | Sheathes Ultrasound Probe Covers Sheathing Technologies, Inc., Mar 4, 2016 |