Class II — Dornier Medtech America, Inc.
| Recalling firm | Dornier MedTech America, Inc. |
|---|---|
| Registered facility | DORNIER MEDTECH AMERICA, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Pin hole package failures compromising sterility of 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 fiber K2011828 400 micron 5X reusable fiber K1010500 600 micron fibertome fiber K2012021 600 micron single use fiber K1015640 AngioSpot Fiber Kit K2012393 600 micron single use fiber K2010292 400 micron single use fiber K2012439 600 micron 5X reusable fiber K2010667 micron ITT fiber K2012875 600 micron 3X reu… |
| Quantity | 400 units |
| Distribution | US Nationwide distribution. |
| Initiated | 2019-04-01 |
| Classified | 2019-05-21 |
| Terminated | 2020-04-20 |
| Recall number | Z-1381-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Dornier Medtech America, Inc. (Z-1381-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82625/
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