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HOPKINS recallZ-3218-2024 · Karl Storz Endoscopy · initiated Jul 23, 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

Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

FDA root cause category: Process design

What the company is doing

On August 2, 2024, Karl Storz -Endoskope issued a "Urgent: Medical Device Correction" Notification to affected consignees via UPS Ground. Karl Storz asked consignees to take the following actions: 1. Immediately discard any previous revisions of the IFU. 2. Access the updated e-IFU at Karl Storz website 3. Pass on this Urgent Medical Device Correction to all users of the products listed and all other persons who need to be aware within your organization. 4. If you have further distributed the products listed, please identify and promptly notify those recipients of this notice and updated e-IFU. 5. 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. 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-3218-2024
Status
Open, Classified
Initiated by the company
Jul 23, 2024
Posted by the FDA
Sep 24, 2024
Recalling firm
Karl Storz Endoscopy
Quantity
425 units
Product code
FGA
FDA submissions
K232370
Distribution
US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, Guam.

Product description

Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123

Code information (models, lots, serial numbers)

All Lots/UDI: (01)04048551233344

Devices named in this recall

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

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 95220).

Sources and updates

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