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This page describes products and general use; it is not medical advice.
An ultrasound probe cover (also called a sheath or sleeve) is a disposable barrier that fits over an ultrasound transducer. It reduces contamination of the probe during a scan, but both the FDA and the CDC state that it does not replace cleaning and disinfection or sterilization of the probe afterwards. Clinic staff, equipment buyers and students use this page to see which uses call for a sterile single-use cover and what a cover does not do.
What an ultrasound probe cover is
A probe cover is a single-use sheath placed over an ultrasound transducer (the probe) so that the probe does not directly touch the patient or the body site being scanned. The FDA’s guidance on diagnostic ultrasound systems calls these “probe sheaths” and says that, after use, the single-use sheath should be removed and discarded. The CDC’s disinfection guideline uses the terms “probe cover” and “sheath” and also describes condoms used for the same purpose.
Who uses them: clinicians and sonographers performing endocavity (for example transvaginal or rectal), intraoperative, biopsy-assisted and other scans where the probe contacts mucous membranes or sterile body sites, and the infection-prevention staff who write the reprocessing policies for those probes.
How a probe cover is built and fitted
The FDA and CDC documents describe a probe cover by what it must do rather than by a parts list. It is a single-use sheath that is drawn over the transducer, and it is removed and discarded after the scan. The CDC also describes a condom as an alternative covering for the same purpose. Where the use requires it, the FDA specifies a sterile sheath, and for neurosurgical use a sterile, non-pyrogenic one (non-pyrogenic means it does not cause fever). Because a cover can be made of natural rubber latex, the FDA says the probe labeling should address the natural rubber safety issues in 21 CFR 801.437, so check each cover’s labeling for latex.
Types and when each is used
Probe covers are not chosen by size or brand alone. The FDA guidance and the CDC guideline sort ultrasound probes by the kind of tissue they touch (the Spaulding categories, explained in our high-level disinfection and Spaulding classification guide), and that determines whether a sterile cover is recommended and what must still happen to the probe afterwards.
| Probe use | Cover recommendation in the source | Probe processing that still applies | Source |
|---|---|---|---|
| Non-critical (contact with intact skin only) | The FDA guidance does not make a cover recommendation for this category | Clean and low-level disinfect between patients | FDA guidance, Appendix E |
| Semi-critical: endoscopic, rectal and transvaginal probes | Use with a single-use sterile sheath; CDC proposes a new condom or probe cover for each patient | Sterilize whenever feasible; high-level disinfection is the minimum acceptable, even if a sheath was used | FDA guidance, Appendix E (special situation 2); CDC guideline |
| Critical: intraoperative, biopsy and other sterile-site use | Sterile sheath recommended for each use | Clean and sterilize after use, even if a sterile sheath was used | FDA guidance, Appendix E; section 5.2.6.1.6.1 |
| Surgical probes (CDC wording) | May be covered with a sterile sheath | Sterilize between patients; if that is not possible, at a minimum high-level disinfect and cover with a sterile probe cover | CDC guideline |
| Neurosurgical (contact with brain tissue or cerebrospinal fluid) | Single-use, sterile, non-pyrogenic sheath | If the patient has known or suspected Creutzfeldt-Jakob disease, the probe should be destroyed | FDA guidance, Appendix E (special situation 1) |
The FDA gives the reason for the neurosurgical row: disinfectant or sterilant residue left on a probe may be neurotoxic, and residual endotoxin is pyrogenic, meaning it causes fevers.
What a cover does not replace
A cover is an added barrier, not a lower category of reprocessing. The FDA states: “the use of sheaths does not change the type of processing that is recommended for the transducer,” and adds that “sheaths can fail during use and the level of resulting contamination may not be easily visible.” The CDC’s Recommendation 10a (Category IB) says: even if probe covers have been used, clean and high-level disinfect rectal and vaginal probes with a high-level disinfectant at the FDA-cleared exposure time. For more on how disinfectants are chosen, see our guide to 70% isopropyl alcohol as a disinfectant.
How often covers fail, according to the CDC
The CDC guideline summarizes published studies of transvaginal probe covers:
| Finding | Reported rate |
|---|---|
| Sterile transvaginal probe covers perforated before use (three suppliers) | 0%, 25% and 65% |
| Used endovaginal probe covers perforated after oocyte retrieval (two suppliers) | 75% and 81% |
| Condoms perforated after use (two studies) | 2.0% and 0.9% |
| Leakage, condoms versus commercially available probe covers (one study) | 1.7% versus 8.3% |
The CDC concludes that these studies “underscore the need for routine probe disinfection between examinations.” The figures come from older studies cited in the 2008 guideline (updated June 2024); they describe the products tested then and are not a ranking of any current product.
How to choose a cover: criteria the sources state
- Sterile where the use requires it. The FDA recommends sterile, legally marketed probe sheaths for semi-critical and critical uses such as intraoperative, transrectal, transvaginal, transesophageal and biopsy procedures.
- Single use. The FDA says endoscopic, rectal and transvaginal probes should be used with a single-use sterile sheath, and that the sheath is discarded after use.
- Non-pyrogenic for neurosurgical use. The FDA specifies a sterile, non-pyrogenic sheath for probes that contact brain tissue or cerebrospinal fluid.
- Named in the probe’s labeling. For endocavity probes the FDA expects the labeling to include validated cleaning and disinfecting instructions and to identify the appropriate sleeves, if available. Check the probe manufacturer’s operator manual for the covers it lists.
- Natural rubber labeling. When probe sheaths are recommended, the FDA says the probe labeling should discuss the natural rubber safety issues described in 21 CFR 801.437. Check each cover’s labeling for whether it contains natural rubber latex.
Safe use and handling basics
- Use a new cover for each patient. The CDC proposes a new condom or probe cover for the probe for each patient.
- Remove and discard the single-use sheath after the scan (FDA guidance, Appendix E).
- Reprocess the probe to the level its use requires even when a cover was used: low-level disinfection for non-critical use, at least high-level disinfection for semi-critical use, sterilization for critical use.
- Follow the probe manufacturer’s labeling for compatible covers and for validated reprocessing methods.
- Coupling gel, which fills the air gap between probe and skin, is covered in our guide to what an ultrasound machine is. For a handheld Doppler example, see the fetal Doppler guide.
Common mistakes
- Treating the cover as a substitute for disinfection. The CDC states not to use a lower category of disinfection or stop following disinfectant recommendations because a cover was used, since sheaths and condoms can fail.
- Assuming a sterile cover is intact. The CDC cites perforations in sterile covers before use.
- Relying on a sheath after a suspected prion exposure. The FDA says the probe sheath should not be relied upon to prevent contamination of the probe when the patient has known or suspected Creutzfeldt-Jakob disease.
- Ignoring latex labeling. The FDA expects probe labeling to address natural rubber when sheaths are recommended.
FAQ
Do you have to use ultrasound gel with a Doppler, and are there different types of gel?
Gel is a coupling medium that removes the air gap between the probe and the skin, as explained in our ultrasound machine guide. The FDA and CDC documents cited here address covers and reprocessing, not gel types or Doppler gel requirements, so follow the probe manufacturer’s instructions for use for any gel question.
Does a probe cover mean the probe needs no disinfection?
No. The FDA and the CDC both state that covers do not change the recommended reprocessing, because covers can fail.
Which scans call for a sterile single-use sheath?
The FDA names endoscopic, rectal and transvaginal probes, and intraoperative, transesophageal and biopsy procedures; for neurosurgical use it specifies a sterile, non-pyrogenic sheath.
Is a condom the same as a probe cover?
The CDC describes condoms as an alternative covering and reports 1.7% leakage for condoms versus 8.3% for commercially available probe covers in one study. Which product a facility uses should follow its infection-prevention policy and the probe’s labeling.
Related supplies
Diagnostic imaging accessories are listed under diagnostic, monitoring and imaging supplies. For equipment cost context, see ultrasound machine cost.
Sources
- U.S. Food and Drug Administration, “Marketing Clearance of Diagnostic Ultrasound Systems and Transducers,” guidance issued June 27, 2019 and reissued February 21, 2023 (sections 5.1.2.9, 5.2.6.1.3, 5.2.6.1.6.1 and Appendix E): fda.gov/media/71100/download. Checked October 30, 2026.
- Rutala WA, Weber DJ, HICPAC, “Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008” (updated June 2024), CDC, semicritical and critical device sections and Recommendation 10: cdc.gov disinfection and sterilization guideline. Checked October 30, 2026.
