Device recall
Z-1006-2026: Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L…
FDA device recall · Class II · Sheathing Technologies Inc
Key facts
| Recall number (Z-number) | Z-1006-2026 |
|---|---|
| Recall event | 98068 |
| 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, |
| Product code | ITX |
| Recalling firm | Sheathing Technologies Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K153212 |
| FEI number | 1000135740 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database