Z-1809-2024Class II

LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000

Name: Z-1809-2024 LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000
Creator: Karl Storz Endoscopy
Published: 2024-04-01
License: https://open.fda.gov/license/

Karl Storz Endoscopy-America, Inc. / initiated 2024-04-01 / Open, Classified / root cause: design

FDA source

Karl Storz Endoscopy began a recall of LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000 on 2024-04-01. FDA classified it as Class II and gives the reason as "Laser surgical instruments have no specific evidence of a validated reprocessing method, therefore these instruments lack sterility assurance, so once the instruments have gone through reprocessing after use and then...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1809-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-01
Posted: 2024-05-13
Recalling firm: Karl Storz Endoscopy-America, Inc.
Product: LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: Laser surgical instruments have no specific evidence of a validated reprocessing method, therefore these instruments lack sterility assurance, so once the instruments have gone through reprocessing after use and then are used again, there is an increased risk of the patient being exposed to infection.
Root cause tag: design
FDA root cause: Device Design
Action: On 4/1/24, recall notices were mailed to representatives for medical product safety, users, operators, distributors who were asked to do the following: 1) Quarantine and discontinue use of affected devices. 2) Pass on the recall notice to all users of the affected devices and to all other persons who need to be aware within your organization. 3) If you have or may have distributed the products listed, please identify and promptly notify those recipients, or provide the recalling firm a list of customers who received/may have received the products listed. 4) Complete and return the customer reply form via email to [email protected] 5) If you have product to return contact the firm at the following phone numbers: For Human Product Telephone: 800-421-0837 Option 1 For Vet Product Telephone: 800-955-7832 Option 1 The firm has placed all affected product on hold and has ceased the distribution of the affected product in the U.S. until further notice. For all other questions regarding this communication, please send an email to [email protected]
Quantity in commerce: 85
Distribution: Worldwide distribution - US Nationwide in the states of OH, CA, FL, MA, TX, KY, WI, MI, MN, AR, NE, IL, NY, HI and the country of Argentina.
Product codes and lots: All lots. REF/UDI-DI: 8694/04048551216392, 461000/04048551164860

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1809-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1809-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-13

Product code GEX

K942786Class IIKarl Storz Laser AccessoriesKARL STORZ Endoscopy-America, Inc. / cleared 1994-09-16

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)