FDA Device recall Z-1006-2026
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 Pro…
- FDA Device
- Class II
- ongoing
- Published 2026-01-07
On 2026-01-07 the FDA classified a Class II recall of 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 Pro… by Sheathing Technologies, citing vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1006-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-11-17 |
| Published | 2026-01-07 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Sheathing Technologies |
| Distribution | US |
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,
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.
Identifiers
| code_info | UDI-DI: 10842418100975. Lot Number: 25-45. Expiration Date: 2028-11-01 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1006-2026%22
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