Stradis Medical, LLC dba Stradis Healthcare: Medical Device Recall in 2021 - (Recall #: Z-0128-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

IUD Insertion Kit

Product Classification:

Class II

Date Initiated: September 10, 2021

Date Posted: October 27, 2021

Recall Number: Z-0128-2022

Event ID: 88656

Reason for Recall:

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

Status: Ongoing

Product Quantity: 14959 kits

Code Information:

Part Number: 935K

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated