Vortex Surgical recalls Rumex Disposable Diamond Dusted ILM Elevator model 12-7523 due to potential voids in Tyvek pouch seals that could cause infection. Affected units have specific catalog numbers and lots.
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Vortex Surgical is recalling its Rumex Disposable Diamond Dusted ILM Elevator (model 12-7523) because flaws in the Tyvek pouch seals might allow contamination, risking infection during surgery. This is serious for medical procedures where sterility is critical.
The Tyvek pouches used to maintain sterility may have small holes or gaps. If these voids allow bacteria to enter, it could lead to infections during surgery, especially in sensitive medical procedures.
Healthcare professionals using this surgical device are most at risk. Patients undergoing procedures with this equipment could face infection if the sterile barrier is compromised.
Check for the model number 12-7523 on the device. Affected units have specific catalog numbers and lots: Pouch UDI 5060720920298 and Box UDI 5060720920298, lot 2411033.
Identify the model number (12-7523) and check the pouch and box UDI numbers for the affected lot.
The recall is due to potential voids in the Tyvek pouch seals that could compromise the sterile barrier, risking infection during surgery.
Check for model 12-7523 with pouch UDI 5060720920298 and box UDI 5060720920298, lot 2411033.
The recall record does not specify a remedy, so contact Vortex Surgical 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-1253-2026 — Vortex Surgical Vortex Surgical Hello, I own a Vortex Surgical that is covered by recall Z-1253-2026 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.
