AVID Medical recalls Halyard LAPAROTOMY GYN PACK model SAMM018-13 due to potential metal flakes entering surgical sites. Affected units sold with lot number 1589639.
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 LAPAROTOMY GYN PACK medical kits (model SAMM018-13) because small metal flakes could detach and enter surgical sites, causing reactions. This poses a risk of local reactions or foreign body reactions in patients during surgery.
The sponge forceps and towel clamps in the kit may release small metal flakes that can enter a patient's surgical site without being detected. This could cause local reactions or foreign body reactions, which might require additional medical intervention.
Healthcare professionals using the Halyard LAPAROTOMY GYN PACK medical kits for surgical procedures are most at risk. Patients undergoing surgery with this kit could experience complications from metal flakes entering their surgical site.
Check for the model number SAMM018-13 on the Halyard LAPAROTOMY GYN PACK kit. Units sold with lot number 1589639 are affected. The kit includes medical convenience items for laparotomy procedures.
Look for model number SAMM018-13 and lot number 1589639 on the kit.
Yes, metal flakes could enter surgical sites causing local reactions or foreign body reactions.
The recall does not specify a remedy, so check product details to see if you have an affected unit.
Look for model number SAMM018-13 and lot number 1589639 on the Halyard LAPAROTOMY GYN PACK kit.
We’ve drafted a message you can send AVID Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0423-2025 — AVID Medical AVID Medical Hello, I own a AVID Medical that is covered by recall Z-0423-2025 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.
