AVID Medical recalls Halyard General Set Up Pack Model ESJH005-02 due to potential metal flakes entering surgical sites. This could cause local reactions or foreign body reactions. Affected units sold with lot number 1583946.
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 its Halyard General Set Up Pack medical convenience kits (model ESJ:005-02) because small metal flakes could detach and enter surgical sites, causing reactions or foreign body issues. This poses a risk to patients during surgery.
Small metal flakes from the sponge forceps and towel clamps might detach during use. If these flakes enter a patient's surgical site, they could cause local reactions or foreign body reactions that may require additional medical intervention.
Medical professionals using the Halyard General Set Up Pack kits for surgical procedures are most at risk. Patients undergoing surgery with these kits could experience local reactions or foreign body reactions.
Check for the model number ESJH005-02 on the Halyard General Set Up Pack. Units sold with lot number 1583946 are affected. This product is a medical convenience kit for surgical procedures.
Identify the model number ESJH005-02 and lot number 1583946 on the Halyard General Set Up Pack.
The recall indicates potential metal flakes could enter surgical sites, so it is not safe to use without checking the recall details.
The recall record does not specify a remedy, so check with AVID Medical for further instructions.
Look for the model number ESJH005-02 and lot number 1583946 on the Halyard General Set Up Pack.
We’ve drafted a message you can send AVID Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0389-2025 — AVID Medical AVID Medical Hello, I own a AVID Medical that is covered by recall Z-0389-2025 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.
