AVID Medical recalls Halyard MAJOR VAGINAL GYN PACK kits with model SAMM021-11 due to potential metal flakes causing surgical site reactions. Affected units sold with lot 1583045.
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 vaginal gyn packs with model SAMM021-11 because metal flakes could detach and enter surgical sites, causing reactions or foreign body issues. This affects medical kits used during procedures.
Small metal flakes from sponge forceps and towel clamps can detach and enter surgical sites undetected. This may cause local reactions or foreign body reactions in patients.
Healthcare providers using these kits during procedures are most at risk. Patients undergoing surgery with this specific model may be affected.
Check for model number SAMM021-11 on the Haly:lyard MAJOR VAGINAL GYN PACK kit. Units sold with lot number 1583045 are affected.
Look for model number SAMM021-11 on the Halyard MAJOR VAGINAL GYN PACK kit.
Reach out to AVID Medical for specific guidance on affected units.
Yes, metal flakes could enter surgical sites causing reactions or foreign body issues.
Check for model number SAMM021-11 and lot number 1583045 on the kit.
Contact AVID Medical for specific guidance on affected units.
We’ve drafted a message you can send AVID Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0424-2025 — AVID Medical AVID Medical Hello, I own a AVID Medical that is covered by recall Z-0424-2025 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.
