Sheathes3D Seamless Viral Barrier — Class II medical device recall Z-1006-2026
Ongoing recall by Sheathing Technologies Inc, reported 2026-01-07, distributed nationwide. Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in cont
| Recall number | Z-1006-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sheathing Technologies Inc, Morgan Hill, CA, United States |
| Recall initiated | 2025-11-17 |
| Classified | 2025-12-31 |
| Reported by FDA | 2026-01-07 |
| Distributed | Nationwide (US) |
| Quantity | 12 |
| UPC / GTIN / UDI-DI | 10842418100975 |
| Lot numbers | 25-45 |
| Model numbers | 76339 |
| Expiration dates | 2028-11-01 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1006-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.