Z-1006-2026Class II

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...

Name: Z-1006-2026 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...
Creator: Sheathing Technologies Inc
Published: 2025-11-17
License: https://open.fda.gov/license/

Sheathing Technologies Inc / initiated 2025-11-17 / Open, Classified / root cause: manufacturing process

FDA source

Sheathing Technologies Inc began a recall of 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... on 2025-11-17. FDA classified it as Class II and gives the reason as "Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1006-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-17
Posted: 2025-12-31
Recalling firm: Sheathing Technologies Inc
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 Transducer, Ultrasonic, Diagnostic
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 11/17/2025, recall notices were emailed to customers asked to do the following: 1) Quarantine products subject to recall. 2) This recall should be carried out to the user level. 3) Complete and return the response form via email to [email protected]
Quantity in commerce: 12
Distribution: US Nationwide distribution in the state of WA.
Product codes and lots: UDI-DI: 10842418100975. Lot Number: 25-45. Expiration Date: 2028-11-01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1006-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1006-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-07	2025-12-31

Product code ITX

K153212Class IISheathes Ultrasound Probe CoversSheathing Technologies, Inc. / cleared 2016-03-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)