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Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE recallZ-1473-2024 · Karl Storz Endoscopy · initiated Feb 27, 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

Inadequate reprocessing validation evidence

FDA root cause category: Under Investigation by firm

What the company is doing

On March 4, 2024, Karl Storz issued a "Urgent: Medical Device Recall" via UPS. Karl Storz asked consignees to take the following actions: 1. Immediately quarantine and discontinue use of associated part numbers listed. 2. Pass on this Urgent Medical Device Recall Notice to all users of the products listed above (Table 1) and 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 KARL STORZ a list of customers who received/may have received the products listed. 4. Return the completed Customer Reply Form by Fax or E-Mail to the indicated contact below within 15 calendar days from the date of receipt. 5. Contact your KARL STORZ representative or call KARL STORZ Customer Support to return affected products. For Human Product: 5a. Call Customer Support at 800-421-0837 Option 1 to set up an RMA. 5b. Or call your KARL STORZ representative to assist with setting up an RMA. For Veterinary Product: 5c. Call KSVEA Customer Support at 800-955-7832 Option 1 to set up an RMA. 5d. Or email [email protected] 6. Please report any incidents related to this issue to the manufacturer, dealer, or local representative and, if applicable, to the national competent authority, as this is important feedback 7. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Recall details

Recall number
Z-1473-2024
Status
Open, Classified
Initiated by the company
Feb 27, 2024
Posted by the FDA
Apr 3, 2024
Recalling firm
Karl Storz Endoscopy
Quantity
27 units
Product code
HET
FDA submissions
K951343
Distribution
US Nationwide distribution in the states of AR, CA, CO, CT, DC, FL, GA, IA, IL, LA, MA, MI, MN, MO , ND, NY, OH, OR, SD, TN, TX, UT, VA, WA, WV.

Product description

Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE

Code information (models, lots, serial numbers)

UDI: 04048551259788/ All Lots

Devices named in this recall

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

Other products in the same recall event

The FDA groups related products into one recall event (event 94171).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page