AVID Medical Halyard GYN PAC Kits Recall: Metal Flakes Risk Surgical Site Reactions

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Contact the company & request your remedy

Recalling firmAVID Medical, Inc.9000 Westmont Dr, N/A · Toano, VA 23168-9351

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

AVID Medical is recalling Halyard GYN PAC medical kits (model SJGY2:02) because small metal flakes could detach and enter surgical sites, causing reactions. This poses a risk of infection or irritation during procedures.

Why it’s dangerous

Metal flakes from the sponge forceps and towel clamps may detach during use. If these flakes enter a surgical site, they can cause local reactions or foreign body reactions that might lead to infection or irritation.

Who’s affected

Healthcare providers using these kits for gynecological procedures are most at risk. Patients undergoing surgery with these kits could experience complications from undetected metal flakes.

How to tell if you have this one

Check for model number SJGY20-02 on the kit. Kits were sold starting April 21, 2016, with lot number 1604218.

Brand
AVID Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Model
Look for model number SJGY20-02 on the Halyard GYN PAC medical convenience kit.
Contact Manufacturer
Reach out to AVID Medical for guidance on next steps if you have the recalled model.

✎ GovInfoNow

Questions people ask

Why is this recall happening?

Metal flakes from sponge forceps and towel clamps could detach and enter surgical sites, causing reactions.

What should I do if I have this kit?

Check the model number; contact AVID Medical for guidance on next steps.

When were these kits sold?

Kits were sold starting April 21, 2016.

Take action

Contact AVID Medical

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

✉️ Open in email

Subject: Recall Z-0436-2025 — AVID Medical AVID Medical

Hello,

I own a AVID Medical that is covered by recall Z-0436-2025 from AVID Medical.

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-0436-2025 (September 20, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0436-2025 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.

AVID Medical, Inc. recalls Halyard GYN PAC - Medical convenience kits Model Number: SJGY20-02

Use caution until it’s fixed