AVID Medical recalls Halyard EP Tray medical kits (model VAST038-04) due to potential metal flakes causing surgical site reactions. Affected units sold with lot number 1595421.
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 Haly: EP Tray medical convenience kits (model VAST038-04) because small metal flakes could detach and enter surgical sites, potentially causing reactions or infections. This risk affects patients during surgery.
The sponge forceps and towel clamps in the kit may release tiny metal flakes during use. These flakes can enter a patient's surgical site without being noticed, leading to local reactions or foreign body reactions.
Medical professionals using the Halyard EP Tray kits during surgery are most at risk. Patients undergoing procedures with these kits could experience surgical site reactions.
Check for the model number VAST038-04 on the Halyard EP Tray kit. Units sold with lot number 1595421 are affected.
Look for model number VAST038-04 on the Halyard EP Tray medical kit.
Reach out to AVID Medical for specific guidance on handling affected kits.
Yes, metal flakes could enter surgical sites and cause reactions or infections.
Check for model number VAST038-04 and lot number 1595421 on the kit.
Contact AVID Medical for specific guidance on handling affected kits.
We’ve drafted a message you can send AVID Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0446-2025 — AVID Medical AVID Medical Hello, I own a AVID Medical that is covered by recall Z-0446-2025 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.