Vortex Surgical recalls 25ga Illuminated Flex-Tip Laser Probes with specific UDI codes due to potential failure to pass through 25ga cannulas smoothly. Affected units may not function correctly during surgical procedures.
Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
Vortex Surgical is recalling certain 25ga Illuminated Flex-Tip Laser Probes that may not pass through 25ga cannulas smoothly. This could cause surgical procedure issues if the probe doesn't move through the cannula properly.
The probe may not pass through a 25ga cannula smoothly, which could lead to procedural complications during surgery. This is a mechanical issue with the probe's design rather than a safety hazard that causes injury.
Surgical professionals using the recalled probes for procedures involving 25ga cannulas. The risk is low as the issue is specific to certain units and not a general failure.
Check for the UDI code on the box or pouch: Box (01)00810123483617(17)281001(10)2509040 or Pouch (01)00810123483549(17)281001(10)2509040. Lot Number 2509040 is also associated with these units.
Look for the UDI code on the box or pouch: Box (01)00810123483617(17)281001(10)2509040 or Pouch (01)00810123483549(17)281001(10)2509040.
The recall is due to some products in this lot not passing through a 25ga cannula smoothly, which could cause surgical procedure issues.
Check for the UDI code on the box or pouch: Box (01)00810123483617(17)281001(10)2509040 or Pouch (01)00810123483549(17)281001(10)2509040. Lot Number 2509040 is also associated with these units.
The recall does not specify a remedy, so contact Vortex Surgical directly for guidance.
We’ve drafted a message you can send Vortex Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1004-2026 — Vortex Surgical Vortex Surgical Hello, I own a Vortex Surgical that is covered by recall Z-1004-2026 from Vortex Surgical. 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.