Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Standard IUD Insertion Kit Recalled by Stradis Medical, LLC dba Stradis Healthcare Due to Firm unable to confirm that the tenaculum devices...

Date: September 10, 2021
Company: Stradis Medical, LLC dba Stradis Healthcare
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Stradis Medical, LLC dba Stradis Healthcare directly.

Affected Products

Standard IUD Insertion Kit

Quantity: 280 kits

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Stradis Medical, LLC dba Stradis Healthcare

Stradis Medical, LLC dba Stradis Healthcare has 93 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report