Stradis Medical, LLC dba Stradis Healthcare recalls Endometrial Biopsy Kit

Recall date

September 10, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0129-2022

FDA classification

Class II

Brand / firm

Stradis Medical, LLC dba Stradis Healthcare

Sold / distributed

Distributed nationwide to VA, SC, CA, PA, MA, FL, TN, NJ, GA, AZ, IL, OH, OK, WA, NY, NV, MO, MD, IN, TX, CO, RI, NC, KY, MT, VI, GA, KS, MI, AK, ID, SD, UT and internationally to Canada.

Why it was recalled

Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Endometrial Biopsy Kit