Z-3221-2024Class II

Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123

Name: Z-3221-2024 Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123
Creator: Karl Storz Endoscopy
Published: 2024-07-23
License: https://open.fda.gov/license/

Karl Storz Endoscopy-America, Inc. / initiated 2024-07-23 / Open, Classified / root cause: manufacturing process

FDA source

Karl Storz Endoscopy began a recall of Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123 on 2024-07-23. FDA classified it as Class II and gives the reason as "Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3221-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-23
Posted: 2024-09-24
Recalling firm: Karl Storz Endoscopy-America, Inc.
Product: Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123
Product code: FGA Kit, Nephroscope
Reason for recall: Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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.)
Quantity in commerce: 109 UNITS
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 codes and lots: All Lots/UDI: (01)04048551233795

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3221-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3218-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-24
Z-3219-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-24
Z-3220-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-24
Z-3221-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-24
Z-3222-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-24
Z-3223-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-24
Z-3224-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-24
Z-3225-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-24

Product code FGA

K232370Class IIPercutaneous Nephroscope SystemKarl Storz SE & CO. KG / cleared 2024-05-01

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)