AVID Medical recalls Halyard AORTA PACK medical kits with model ESJH004-02 due to potential metal flakes causing surgical site reactions. Affected units sold from 2021-01-01 to 2021-06-30.
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 AORTA PACK medical kits (model ESJH0:02) because small metal flakes could detach and enter surgical sites, causing reactions. This poses a risk to patients during surgery.
The sponge forceps and towel clamps in the kit may release small metal flakes during use. These flakes can enter the surgical site undetected, leading to local reactions or foreign body reactions.
Healthcare professionals using the Halyard AORTA PACK kits for surgical procedures are most at risk. Patients undergoing surgery with these kits could experience complications.
Check for the model number ESJH004-02 on the Halyard AORTA PACK kit. Units were sold between January 2021 and June 2021.
Look for the model number ESJH004-02 on the Halyard AORTA PACK kit.
Small metal flakes could detach from the sponge forceps and towel clamps and enter the surgical site, causing local reactions or foreign body reactions.
Check for the model number ESJH004-02 on the Halyard AORTA PACK kit. Units were sold between January 2021 and June 2021.
The recall record 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-0388-2025 — AVID Medical AVID Medical Hello, I own a AVID Medical that is covered by recall Z-0388-2025 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.
