Dornier Diode Laser Fibers Recalled for Sterility Compromise
Dornier Medtech America is recalling 400 units of Dornier Diode Laser Fibers due to pin hole package failures that compromise product sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (sterility compromise) where specific injury reports are not detailed in the source text, fitting the High severity criteria for risk-of-harm products.
Plain-English summary
Dornier Medtech America, Inc. is recalling 400 units of Dornier Diode Laser Fibers used with Dornier Medilas D Family Lasers. The recall is due to pin hole package failures that compromise the sterility of the product. The affected products include various single-use and reusable fiber part numbers, such as K1001291, K2011824, and K1001293.
The Dornier Diode Fibers are accessories used in medical and surgical procedures across specialties including Urology, Plastic Surgery, and Dermatology. The lasers are intended for cutting, vaporization, ablation, and coagulation of soft tissue. The recall covers all lot numbers and was distributed nationwide in the United States.
Healthcare facilities and consumers should stop using the affected Dornier Diode Laser Fibers immediately. Users should contact Dornier Medtech America, Inc. for instructions on returning the product or obtaining a replacement.
The recalled product
- Product
- Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part Number/Description: K1001291 600 micron single use fiber K2011824 600 micron single use fiber K1001293 600 micron single use fiber K2011826 600 micron 5X reusable fiber K1008084 600 micron single use…
- Manufacturer
- Dornier Medtech America, Inc.
- Affected units
- 400
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lot numbers
Distribution
Distributed nationwide across the United States.
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