Ultrasound probe covers recalled over defects that may cause contamination during use
Sheathing Technologies is recalling 12 units of Sheathes3D vaginal and rectal ultrasound probe covers because product defects may result in contamination during use, posing an infection risk.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states defects may cause contamination during use and pose an infection risk, and no injuries are reported.
Plain-English summary
Sheathes3D Seamless Viral Barrier ultrasound probe covers, latex-free, non-sterile, tapered, rolled, extra-long, individually wrapped in boxes of 50, item number 76339, are being recalled by Sheathing Technologies Inc. The product is a vaginal and rectal probe cover.
Vaginal and rectal ultrasound probe covers with a viral barrier may have product defects, which the firm states may result in contamination during use, posing an infection risk.
The record lists 12 units carrying UDI-DI 10842418100975, from lot 25-45 with an expiration date of 2028-11-01. Distribution was nationwide in the United States, in Washington. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Facilities should quarantine the affected lot and follow the firm's instructions.
The recalled product
- 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,
- Manufacturer
- Sheathing Technologies Inc
- Category
- Medical Device — Probe cover
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 10842418100975. Lot Number: 25-45. Expiration Date: 2028-11-01
Distribution
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