AVID Medical recalls Halyard BIOPSY PACK medical kits with model VANW01:04 due to potential metal flakes causing surgical site reactions. Affected units sold in 2016-2017.
Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
AVID Medical is recalling Halyard BIOPSY PACK medical kits (model VANW019-04) because small metal flakes could detach and enter surgical sites, causing reactions. This poses a risk of infection or foreign body reactions if the kit is used in procedures.
The sponge forceps and towel clamps in the kit can release small metal flakes during use. These flakes may enter a patient's surgical site without being noticed, leading to local reactions or foreign body reactions.
Healthcare professionals using the Halyard BIOPSY PACK kits for medical procedures are most at risk. Patients undergoing surgery with these kits could experience complications from undetected metal flakes.
Check for the model number VANW019-04 on the kit. The product was sold in 2016-2017 with lot number 1609032.
Look for model number VANW019-04 on the Halyard BIOPSY PACK kit.
Yes, metal flakes could enter surgical sites causing reactions or infections.
Check for model number VANW019-04 on the kit; sold in 2016-2017 with lot number 1609032.
The recall does not specify a remedy, so contact AVID Medical for guidance.
We’ve drafted a message you can send AVID Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0440-2025 — AVID Medical AVID Medical Hello, I own a AVID Medical that is covered by recall Z-0440-2025 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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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.
