Dornier recalls specific laser fiber models used with Medilas D Family Lasers due to pin hole package failures that could compromise product sterility. Affected items include K1001291, K2011824, and other 600 micron fibers. Consumers should check their product details.
Pin hole package failures compromising sterility of product
Dornier is recalling certain diode laser fibers used with Medilas D Family Lasers because the packaging may have pin holes that compromise sterility. This could lead to infections if the fibers are used in medical procedures without proper sterilization.
The laser fibers are packaged in a way that may develop pin holes, which could allow contamination and compromise sterility. This means the fibers might not be sterile when used in medical procedures, increasing infection risk.
Medical professionals using Dornier Medilas D Family Lasers for surgery in urology, plastic surgery, dermatology, and other specialties may be affected. Patients undergoing procedures with these lasers are at risk if the fibers are not sterile.
Check for part numbers K1001291, K2011824, K1001293, K2011826, K1008084, K2011828, K1010500, K2012021, K1015640, K2012393, K2010292, K2012439, K2010667, K2012875, K2010710, or K2012879. These fibers are used with Dornier Medilas D Family Lasers for surgical procedures.
Identify the part number on the laser fiber packaging to confirm if it is affected by this recall.
These fibers are used for cutting, vaporization, ablation, and coagulation of soft tissue in urology, plastic surgery, dermatology, gynecology, pulmonary surgery, gastroenterology, ENT, and radiology procedures.
Affected part numbers include K1001291, K2011824, K1001293, K2011826, K1008084, K2011828, K1010500, K2012021, K1015640, K2012393, K2010292, K2012439, K2010667, K2012875, K2010710, and K2012879.
The recall does not require immediate discontinuation; however, you should check if your product is affected and follow the action steps to ensure sterility.
We’ve drafted a message you can send Dornier to request your refund or repair — edit it as you like.
Subject: Recall Z-1381-2019 — Dornier Dornier Hello, I own a Dornier that is covered by recall Z-1381-2019 from Dornier. 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.
