Z-1381-2019Class II

Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part Number/Description: K1001291 600...

Name: Z-1381-2019 Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part Number/Description: K1001291 600...
Creator: Dornier Medtech America, Inc.
Published: 2019-04-01
License: https://open.fda.gov/license/

Dornier Medtech America, Inc. / initiated 2019-04-01 / Terminated / root cause: packaging

FDA source

Dornier Medtech America, Inc. began a recall of Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part Number/Description: K1001291 600 micron single use fiber K2011824 600 micron single... on 2019-04-01. FDA classified it as Class II and gives the reason as "Pin hole package failures compromising sterility of product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1381-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-01
Posted: 2019-05-21
Terminated: 2020-04-20
Recalling firm: Dornier Medtech America, Inc.
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 reusable fiber K2010710 400 micron single use fiber K2012879 400 micron 3X reusable fiber K2011822 400 micron single use fiber Product Usage: The Dornier Diode Fibers are accessories to the Dornier Medilas D Family Lasers. The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT, and Radiology. The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse. and Medilas D MagnaPulse, are intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), in the treatment and/or removal of vascular lesions (tumors) and removal of unwanted hair, for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux and treatment of reticular veins and branch varicosities. The Dornier Medilas D Family Lasers, specifically the Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 28-85 cc.
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: Pin hole package failures compromising sterility of product
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Dornier MedTech America notified customers by telephone and follow-up by letter sent Certiied Mail on 4-10-19. Accounts advised of problem, health risk and action to take: The customer should immediately quarantine all inventory of Dornier Diode Laser Fibers and return all product to Dornier per the provided instructions. Contact the Dornier Quality Department at 1-800-367-6437
Quantity in commerce: 400 units
Distribution: US Nationwide distribution.
Product codes and lots: All lot numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1381-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1381-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-29	2019-05-21

Product code GEX

K083500Class IIMedilas D Family Lasers, Including Medilas D Litebeam, Litebeam +, Urobeam, Multibeam, Flexipulse and MagnapulseDornier Medtech America, Inc. / cleared 2009-02-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)