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-Ster
FDA device recall Z-1006-2026 · posted 2025-12-31 · Open, Classified
Recall details
- Recalling firm
- Sheathing Technologies Inc
- 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.
- Action taken
- 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
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- ITX
- Quantity affected
- 12
- Distribution
- US Nationwide distribution in the state of WA.
- Date initiated
- 2025-11-17
- Date posted
- 2025-12-31
- Location
- Morgan Hill, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Sheathes Ultrasound Probe Covers (K153212) | Sheathing Technologies, Inc. | 2016-03-04 |