Z-0837-2025Class II

Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE

Name: Z-0837-2025 Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE
Creator: Karl Storz Endoscopy
Published: 2024-12-19
License: https://open.fda.gov/license/

Karl Storz Endoscopy-America, Inc. / initiated 2024-12-19 / Open, Classified / root cause: sterility

FDA source

Karl Storz Endoscopy began a recall of Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE on 2024-12-19. FDA classified it as Class II and gives the reason as "Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0837-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-12-19
Posted: 2025-01-10
Recalling firm: Karl Storz Endoscopy-America, Inc.
Product: Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE
Product code: LRC Instrument, Ent Manual Surgical
Reason for recall: Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance.
Root cause tag: sterility
FDA root cause: Reprocessing Controls
Action: On December 19, 2024, Karl Storz issued a "Urgent: Medical Device Recall" Notification to affected consignees. In addition to informing consignees about the recall, Karl Storz ask 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 recalled product and all other persons who need to be aware within your organization. 3. If you have further distributed the recall product, please identify and promptly notify those recipients by providing a copy of the recall notification and response form, or provide KARL STORZ a list of customers who received/may have received the product 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 product. " Call Customer Support at 800-421-0837 Option 1 to set up an RMA. " Or call your KARL STORZ representative to assist with setting up an RMA. 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: 285 units
Distribution: US: AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OR, PA, SC, TX, VA OUS: None
Product codes and lots: Lot Numbers: All lots of the affected material number/Primary DI Number: 04048551194416

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0837-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0837-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-10

Product code LRC

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)