AVID Medical recalls Halyard Lower Extremity Pack Model PANJ001-03 due to potential metal flakes causing surgical site reactions. Affected units sold with specific lot numbers.
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 Lower Extremity Pack medical kits because small metal flakes could detach and enter surgical sites, causing reactions or infections. This affects patients who have received the specific model with listed lot numbers.
The sponge forceps and towel clamps in the kit can release tiny metal flakes that may enter a patient's surgical site without detection. This could lead to local reactions or foreign body reactions, though the risk is not immediate or severe.
Patients using the Halyard Lower Extremity Pack medical kits for surgical procedures are most at risk. The recall applies to specific lot numbers produced between August 2016 and early 2017.
Check for the model number PANJ001-03 on the product. Affected units include specific lot numbers: 1608129, 1608518, and 1610934.
Look for the model number PANJ001-03 and affected lot numbers: 1608129, 1608518, 1610934.
The recall states metal flakes could detach and enter surgical sites, but the risk is not immediate or severe. The product is not considered dangerous under normal use.
Check for the model number PANJ001-03 and affected lot numbers: 1608129, 1608518, 1610934.
The recall does not specify a remedy, so no action is required beyond checking if you have the affected model and lot numbers.
We’ve drafted a message you can send AVID Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0419-2025 — AVID Medical AVID Medical Hello, I own a AVID Medical that is covered by recall Z-0419-2025 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.