FDA Device recall Z-0184-2022
FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)
- FDA Device
- Class II
- ongoing
- Published 2021-11-10
On 2021-11-10 the FDA classified a Class II recall of FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units) by Karl Storz Endoscopy, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0184-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-09-10 |
| Published | 2021-11-10 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Karl Storz Endoscopy |
| Distribution | AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV |
Product
FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)
Reason
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.
Identifiers
| code_info | All LOTs with remaining shelf life |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0184-2022%22
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