Z-1474-2024Class II

Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only, Rx Only

Name: Z-1474-2024 Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only, Rx Only
Creator: Karl Storz Endoscopy
Published: 2024-02-27
License: https://open.fda.gov/license/

Karl Storz Endoscopy-America, Inc. / initiated 2024-02-27 / Open, Classified

FDA source

Karl Storz Endoscopy began a recall of Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only, Rx Only on 2024-02-27. FDA classified it as Class II and gives the reason as "Inadequate reprocessing validation evidence". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1474-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-27
Posted: 2024-04-03
Recalling firm: Karl Storz Endoscopy-America, Inc.
Product: Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only, Rx Only
Product code: LRC Instrument, Ent Manual Surgical
Reason for recall: Inadequate reprocessing validation evidence
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 147 Units
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 codes and lots: UDI: 04048551193587/ All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1474-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1472-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-04-03
Z-1473-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-04-03
Z-1474-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-04-03

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)