Five S 5 3x65, REF: 0915612-06, sterile for single use… recallZ-2589-2023 · Karl Storz Endoscopy · initiated Jul 7, 2023

Open, Classified

Is my device affected?

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.
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.
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

Flexible intubation endoscopes sterility assurance can not be confirmed.

FDA root cause category: Process change control

What the company is doing

On August, 4, 2023, Karl Storz Endoscopy issued an Urgent Medical Device Recall Notification via: UPS. Karl Storz asked consignees to take the following actions: 1. Immediately quarantine and discontinue use of Material numbers listed above. 2. Pass on this Urgent Medical Device Recall notice to all users of the products listed above and all other persons who need to be aware within your organization. 3. If you have distributed the products listed, please promptly forward this letter to those recipients, and indicate contact details of the recipient on the Customer Reply From. 4. Return the filled Customer Reply Form by Fax or E-Mail to the indicated contact. 5. Get in touch with your KARL STORZ representative to return affected products. 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-2589-2023
Status: Open, Classified
Initiated by the company: Jul 7, 2023
Posted by the FDA: Sep 15, 2023
Recalling firm: Karl Storz Endoscopy
Quantity: 218 units
Product code: EOQ
FDA submissions: K212656
Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MEX, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Canada.

Product description

Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only

Code information (models, lots, serial numbers)

UDI: 04048551446690/ All lots with remaining shelf life (Globally) Lots imported into the U.S.: 500472 & 500461

Devices named in this recall

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

N/A 0915612-06
Karl Storz GmbH & Co. KG · Bronchoscope (flexible or rigid)
1 recall3 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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