Stradis Healthcare Endometrial Biopsy Kit Recall: Design Standards Uncertainty

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Recalling firmStradis Medical, LLC dba Stradis Healthcare3025 Northwoods Pkwy, N/A · Peachtree Corners, GA 30071-1524

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Stradis Healthcare is recalling an Endometrial Biopsy Kit (Part Number 936K) because they cannot confirm it was made to the required design and manufacturing standards. This recall does not specify a remedy or hazard that would require immediate action.

Why it’s dangerous

The recall states that Stradis Healthcare cannot confirm the tenaculum devices meet required design and manufacturing standards. This uncertainty means the kit might not function safely during medical procedures, potentially leading to complications.

Who’s affected

Healthcare providers who use the Endometrial Biopsy Kit (Part 936K) are likely affected. Patients using the kit under medical supervision are at minimal risk if the kit is used correctly.

How to tell if you have this one

Check for the Endometrial Biopsy Kit with Part Number 936K. The product was sold by Stradis Healthcare.

Brand
Stradis Healthcare
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the kit's part number (936K) to confirm if it is recalled.

✎ GovInfoNow

Questions people ask

Is there a specific action I need to take for this recall?

The recall notice does not specify any action steps.

What is the hazard with this product?

The manufacturer cannot confirm the tenaculum devices meet required design and manufacturing standards.

How can I tell if I have the recalled product?

Look for the Endometrial Biopsy Kit with Part Number 936K.

Take action

Contact Stradis Healthcare

We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0129-2022 — Stradis Healthcare Stradis Healthcare

Hello,

I own a Stradis Healthcare that is covered by recall Z-0129-2022 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.

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Where this comes from

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.

Official source: FDA Recall #Z-0129-2022 (September 10, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0129-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Stradis Medical, LLC dba Stradis Healthcare recalls Endometrial Biopsy Kit

Recall notice