Stradis Healthcare Loop Recorder Pack Recall: Risk of Sterility Breach

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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 loop recorder packs that may have incomplete bag sealing, risking sterility breaches during medical procedures. This could lead to infections if the kit is used without proper sterility.

Why it’s dangerous

The outer bag may not seal properly during manufacturing, creating a breach in the kit's sterility. This could allow contamination if the kit is used without being sterile, increasing infection risk during medical procedures.

Who’s affected

Healthcare professionals using the loop recorder packs for medical procedures are most at risk. Patients using these kits during surgery could face infection if sterility is compromised.

How to tell if you have this one

Check for item number 570-2891 on the loop recorder pack. Look for UDI/DI (case) H65857028911 and UDI/DI (kit) M75257028910. Serial numbers start with 22252491813.

Brand
Stradis Healthcare
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the item number, UDI/DI codes, and serial numbers to confirm if your loop recorder pack is affected.

✎ GovInfoNow

Questions people ask

What is the specific item number for the recalled loop recorder pack?

The item number is 570-2891.

What UDI/DI codes are associated with the recalled product?

UDI/DI (case) H65857028911 and UDI/DI (kit) M75257028910.

What serial numbers are affected?

Serial numbers starting with 22252491813.

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-0522-2023 — Stradis Healthcare Stradis Healthcare

Hello,

I own a Stradis Healthcare that is covered by recall Z-0522-2023 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-0522-2023 (November 2, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0522-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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 HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891

Lower-risk recall