AVID Medical Halyard IR Biopsy Pack Recall: Metal Flakes Risk

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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 IR Biopsy Packs (model AVMD019-01) because small metal flakes could detach and enter surgical sites, causing reactions or foreign body issues. This affects medical devices used during procedures.

Why it’s dangerous

The sponge forceps and towel clamps in the biopsy pack can release small metal flakes during use. These flakes may enter the surgical site undetected, leading to local reactions or foreign body reactions in patients.

Who’s affected

Medical professionals using the Halyard IR Biopsy Pack for surgical procedures are most at risk. Patients undergoing surgery with this device may experience local reactions or foreign body reactions.

How to tell if you have this one

Check for the model number AVMD019-01 on the Halyard IR Biopsy Pack. Units sold with lot number 1583034 are affected. The product is a medical convenience kit for surgical procedures.

Brand
AVID Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for model number AVMD019-01 and lot number 1583034 on the Halyard IR Biopsy Pack.

✎ GovInfoNow

Questions people ask

Is this product dangerous for patients?

Yes, metal flakes could enter surgical sites causing local reactions or foreign body reactions.

How can I tell if I have the recalled product?

Check for model number AVMD019-01 and lot number 1583034 on the Halyard IR Biopsy Pack.

What should I do if I have this product?

The recall does not specify a remedy, so contact AVID Medical for guidance.

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-0384-2025 — AVID Medical AVID Medical

Hello,

I own a AVID Medical that is covered by recall Z-0384-2025 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-0384-2025 (September 20, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0384-2025 to see it in context.
Plain-language summary written by qwen3:4b on September 23, 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 IR BIOPSY PACK - Medical convenience kits Model Number: AVMD019-01

Lower-risk recall