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LASER Application Instrument, 23 cm, REF: 8694 recallZ-1809-2024 · Karl Storz Endoscopy · initiated Apr 1, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Karl Storz Endoscopy or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

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]

Recall details

Recall number
Z-1809-2024
Status
Open, Classified
Initiated by the company
Apr 1, 2024
Posted by the FDA
May 13, 2024
Recalling firm
Karl Storz Endoscopy
Quantity
85
Product code
GEX
FDA submissions
K942786
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 description

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

Code information (models, lots, serial numbers)

All lots. REF/UDI-DI: 8694/04048551216392, 461000/04048551164860

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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