Sheathes3DRecalls & reported problems across all models
Sheathing Technologies, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Sheathes3D model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 2 models of Sheathes3D by Sheathing Technologies, Inc. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Aug 18, 2021 and Aug 18, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (1 report).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Sheathes3D recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Nov 17, 2025Open, Classified
Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
Z-1006-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported Sheathes3D problems
Device problems
- Loss of or Failure to Bond1
Patient problems
- Insufficient Information1
Sheathes3D models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Sheathes3D 76339Transducer, Ultrasonic, Diagnostic1 recall0 reports
- Sheathes3D ADH-35-4Transducer, Ultrasonic, Diagnostic1 report
Recent Sheathes3D adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2021Loss of or Failure to Bond
SHEATHING TECHNOLOGIES, INC. SHEATHES3D ULTRASOUND ADHESIVE PATCH DOES NOT HAVE ADHESIVE /GEL, THEREFORE DOES NOT ADHERE TO THE US PROBE COVER. UNABLE TO USE PRODUCT AS INTENDED.
Patient problems: Insufficient Information
MAUDE report 12335804 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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