Alcon recalls Legion FMS Pak devices with potential plastic debris from over-tightening. Affected units include specific catalog numbers and product codes. Stop using immediately to prevent injury during procedures.
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
Alcon is recalling Legion FMS Pak devices that may shed plastic debris if over-tightened with the included wrench, which could cause injury during medical procedures. This recall affects specific product models sold with certain catalog numbers and product codes.
Over-tightening the device with the included plastic wrench can cause plastic debris to shed. This debris may cause injury during medical procedures if it enters the patient's body or equipment.
Medical professionals using the Legion FMS Pak during procedures are most at risk. Patients receiving these devices may be affected if the plastic debris causes injury.
Check for catalog numbers 8065753164, 8065753165, or 8065753166 on the device. Product codes 100205822, 100207728, or 100207729 are also associated with this recall.
Discontinue use of the Legion FMS Pak if it has the affected catalog numbers or product codes listed in the recall notice.
Over-tightening the device with the included plastic wrench can cause plastic debris to shed, which may cause injury during medical procedures.
Legion FMS Pak with catalog numbers 8065753164, 8065753165, 8065753166 and product codes 100205822, 100207728, 100207729.
The recall does not specify a return process, so contact Alcon directly for guidance.
We’ve drafted a message you can send Alcon to request your refund or repair — edit it as you like.
Subject: Recall Z-2409-2023 — Alcon Alcon Hello, I own a Alcon that is covered by recall Z-2409-2023 from Alcon. 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.
