AVID Medical recalls shoulder surgical kits with potential metal flakes causing surgical site reactions. Affected model ESJH014-06 may need replacement to prevent foreign body reactions.
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 shoulder surgical kits that could have small metal flakes detach and enter surgical sites, potentially causing reactions or infections. This is serious because metal flakes might go unnoticed during surgery.
Small metal flakes could detach from the kit's components during use. These flakes might enter a patient's surgical site without being noticed, causing local reactions or foreign body reactions that could lead to infections.
Healthcare professionals using the Halyard Shoulder Kit model ESJ:JH014-06 for surgical procedures are most at risk. Patients undergoing surgery with this kit could face complications from undetected metal flakes.
Check for the model number ESJH014-06 on the kit. The kit was sold with lot number 1610214 and GTIN 10809160423226.
The recalled Halyard Shoulder Kit model ESJH014-06 should be stopped from use to prevent potential metal flakes from entering surgical sites.
Yes, metal flakes could enter surgical sites undetected, causing reactions or infections.
Stop using it immediately and contact AVID Medical for replacement.
Look for model number ESJH014-06 with lot number 1610214 or GTIN 10809160423226.
We’ve drafted a message you can send AVID Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0391-2025 — AVID Medical AVID Medical Hello, I own a AVID Medical that is covered by recall Z-0391-2025 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
