Stradis Healthcare recalls Standard IUD Insertion Kit (Part M20) due to unconfirmed compliance with design and manufacturing standards. Consumers should contact the company for details.
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
Stradis Healthcare is recalling its Standard IUD Insertion Kit (Part M20) because they cannot confirm it was made to the required design and manufacturing standards. This could mean the kit might not work safely during medical procedures.
The manufacturer cannot confirm the kit meets required design and manufacturing standards. This uncertainty means the kit might not function safely during medical procedures, potentially causing complications.
Women who use this IUD insertion kit for medical procedures are affected. Healthcare providers using the kit are at risk of potential safety issues.
Check for the product name 'Standard IUD Insertion Kit' and part number M20. The kit was sold by Stradis Healthcare.
Reach out to Stradis Healthcare directly for specific instructions on handling the recalled kit.
The manufacturer cannot confirm the kit meets required design and manufacturing standards, so the risk is unknown.
Contact Stradis Healthcare directly for specific instructions on handling the recalled kit.
Check for the product name 'Standard IUD Insertion Kit' and part number M20.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0131-2022 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0131-2022 from Stradis Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
