AVID Medical recalls endovascular surgical kits with model SAMM048-15 due to potential metal flakes causing surgical site reactions. Affected units include specific lot numbers and GTIN.
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 endovascular surgical kits that may release small metal flakes during use. These flakes could enter a patient's surgical site, causing reactions or foreign body issues. This is a serious risk for surgical procedures.
The surgical kit components can shed small metal flakes that may enter a patient's surgical site without detection. This could lead to local reactions or foreign body reactions, which are serious medical complications.
Surgical teams and hospitals using the Haly: OR Endovascular Tray kits with model SAMM048-15 are affected. Patients undergoing surgery with these kits face the highest risk of complications.
Check for the model number SAMM048-15 on the kit. Affected units include specific lot numbers 1590860 and 1593416, and GTIN 10809160384206.
Immediately stop using the Halyard OR Endovascular Tray kits with model SAMM048-15 as they may release metal flakes that could cause surgical site reactions.
The model number is SAMM048-15.
Lot numbers 1590860 and 1593416 are affected.
Check for the model number SAMM048-15 and lot numbers 1590860 or 1593416 on the kit, or GTIN 10809160384206.
We’ve drafted a message you can send AVID Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0427-2025 — AVID Medical AVID Medical Hello, I own a AVID Medical that is covered by recall Z-0427-2025 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.
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