Z-2589-2023Class II

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

Name: Z-2589-2023 Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
Creator: Karl Storz Endoscopy
Published: 2023-07-07
License: https://open.fda.gov/license/

Karl Storz Endoscopy-America, Inc. / initiated 2023-07-07 / Open, Classified / root cause: sterility

FDA source

Karl Storz Endoscopy began a recall of Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only on 2023-07-07. FDA classified it as Class II and gives the reason as "Flexible intubation endoscopes sterility assurance can not be confirmed". 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-2589-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-07
Posted: 2023-09-15
Recalling firm: Karl Storz Endoscopy-America, Inc.
Product: Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
Product code: EOQ Bronchoscope (Flexible Or Rigid)
Reason for recall: Flexible intubation endoscopes sterility assurance can not be confirmed.
Root cause tag: sterility
FDA root cause: Process change control
Action: 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.)
Quantity in commerce: 218 units
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 codes and lots: UDI: 04048551446690/ All lots with remaining shelf life (Globally) Lots imported into the U.S.: 500472 & 500461

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2589-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2589-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-27	2023-09-15

Product code EOQ

K212656Class IIFlexible Intubation Video Endoscope – Sterile (FIVE-S)Karl Storz Endoscopy America / cleared 2021-12-29

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)