Sheathes3D ADH-35-4Recalls & reported problems
Sheathing Technologies, Inc. · Seamless Viral Barrier Adhesive Patch, Latex-Free, 1.5"W x 4.5"L on 3"W x 5"L, Sterile, Ultrasound Probe Cover, Individually Wrapped · Class 2
All models of Sheathes3D (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10842418102085), 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 other recall cover devices cleared under the same FDA submission (K153212); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Loss of or Failure to Bond1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, 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 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K153212. One submission often covers many models, so check the product and lot details in each record.
- Z-1006-2026 · Nov 17, 2025 · Open, ClassifiedSheathes3D 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
Other Transducer, Ultrasonic, Diagnostic devices
- Site~Rite 8 Ultrasound System 9770603Bard Access Systems, Inc. · Transducer, ultrasonic, diagnostic620 reports
- ULTRASONIC PROBE UM-S20-17SOlympus Medical Systems Corp. · Transducer, ultrasonic, diagnostic2 deaths344 reports
- Transducer X7-2t 989605414122Philips Ultrasound LLC · Transducer, ultrasonic, diagnostic6 recalls21 reports
- EPIQ Diagnostic Ultrasound System 989605488741Philips Ultrasound LLC · Transducer, ultrasonic, diagnostic3 recalls165 reports
- bk3000, bk3500, bk5000, bkActiv 2300Bk Medical Aps · Transducer, Ultrasonic, Diagnostic6 recalls1 report
- Transducer L12-3 989605412072Philips Ultrasound LLC · Transducer, ultrasonic, diagnostic5 recalls1 report
- Transducer eL18-4 EMT 989605431531Philips Ultrasound LLC · Transducer, ultrasonic, diagnostic5 recalls0 reports
- Transducer L12-3 Ergo 989605492481Philips Ultrasound LLC · Transducer, ultrasonic, diagnostic5 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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