EnCor EnCompass Breast Biopsy and Tissue Removal System Console
The breast biopsy system may experience errors that interrupt or prolong the procedure.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Bard Peripheral Vascular Inc recalled the EnCor EnCompass Breast Biopsy and Tissue Removal System Console and Driver with software on August 20, 2026, because the system may experience probe calibration or handheld driver failure, or a pressure sensor error, which may interrupt or prolong the biopsy procedure or the need for additional tissue sampling or repeat biopsy. The FDA added the recall to its Enforcement Report on September 25, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and UDI-DI listed under your product.
EnCor EnCompass Breast Biopsy and Tissue Removal System Console (
- Model
- ENCPCONSOLE
- UDI-DI
- 00801741235221
- 00801741234248
Details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Kansas, South Carolina, California, Texas, Georgia, North Carolina, Pennsylvania, South Carolina, Idaho, Michigan, Kentucky, Connecticut, Illinois, Virginia, Massachusetts, Wisconsin, New York, Indiana, Tennessee, Ohio, Utah.
- Event ID
- 99590
- Recall No.
- Z-3275-2026
- Company
- Bard Peripheral Vascular IncTempe, Arizona
- Hazard
- Device defect
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
Summary updated
In FDA's weekly enforcement report
