FDA DevicesClass II
Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (...
Published: January 7, 2026Recall ID: Z-1006-2026Category: devicesCountry: US
Reason for Recall / Hazard
Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
Product Description & Identification
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,
Additional Source Details
| Field | Value |
|---|---|
| City | Morgan Hill |
| State | CA |
| Event id | 98068 |
| Address 1 | 675 Jarvis Dr |
| Address 2 | N/A |
| Code info | UDI-DI: 10842418100975. Lot Number: 25-45. Expiration Date: 2028-11-01 |
| Postal code | 95037-2815 |
| Report date | 20260107 |
| Product type | Devices |
| Product quantity | 12 |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251117 |
| Initial firm notification | Letter |
| Center classification date | 20251231 |
Overview
- Recalling FirmSheathing Technologies Inc
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the state of WA.