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Sheathes3D
SHEATHING TECHNOLOGIES, INC. · Model 76339 · UDI-DI 10842418100975
1
510(k) clearances
3,948
Adverse events (23 deaths)
147
Recalls
396
Facilities
Description
Seamless Viral Barrier, Polyurethane, 7/8"D Tapered to 2.9"W x 11.8"L, Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled, Extra-Long, Individually Wrapped
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-17 | Sheathing Technologies Inc | Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| 2025-09-05 | Philips Ultrasound, Inc | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.