Z-0184-2022Class II

FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)

Name: Z-0184-2022 FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)
Creator: Karl Storz Endoscopy
Published: 2021-09-10
License: https://open.fda.gov/license/

Karl Storz Endoscopy-America, Inc. / initiated 2021-09-10 / Open, Classified / root cause: sterility

FDA source

Karl Storz Endoscopy began a recall of FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units) on 2021-09-10. FDA classified it as Class II and gives the reason as "During a regular requalification review, affected flexible intubation video endoscopes did not achieve the required sterility assurance level. There is a risk that the patient may be exposed to a higher risk of infection". 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-0184-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-09-10
Posted: 2021-10-29
Recalling firm: Karl Storz Endoscopy-America, Inc.
Product: FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)
Product code: CAL Laryngoscope, Non-Rigid
Reason for recall: During a regular requalification review, affected flexible intubation video endoscopes did not achieve the required sterility assurance level. There is a risk that the patient may be exposed to a higher risk of infection.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: On 09/10/21 recall notices were mailed to customers. Action to be taken by the user 1. Immediately quarantine and discontinue use of the affected products. 2. Pass on this Urgent Field Safety 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 affected products to third parties, please promptly forward this letter to the recipients of the products and indicate contact details of the recipient on the Acknowledgement and Response Form. 4. Return the Acknowledgment and Response Form by Fax or E-Mail to the contact listed below within 10 calendar days of receipt of this notice. 5. Get in touch with your KARL STORZ representative to return affected products and to discuss suitable alternative products. This notice must be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Complete and return the Customer Acknowledgement and Response Form.
Quantity in commerce: 532
Distribution: US: SC, NH, UT, LA, FL, TX, MA, MO, VA, IA, CA, IL, NC, VT, AL, GA, PA, TN, WI, NY, CO, AZ, NV, ME, MS, DC, IN, KY, MD, OH, MI, WA, KS, OR, AR, MN, NJ, NM, WV, CT. OUS: Canada
Product codes and lots: All LOTs with remaining shelf life

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0184-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0184-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-11-10	2021-10-29

Product code CAL

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)