FIVE S 3 — Class II medical device recall Z-0184-2022
Ongoing recall by Karl Storz Endoscopy, reported 2021-11-10, distributed in AL, AR, AZ, CA, CO, CT, DC, FL…. During a regular requalification review, affected flexible intubation video endoscopes did not achieve the req
| Recall number | Z-0184-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Karl Storz Endoscopy, El Segundo, CA, United States |
| Recall initiated | 2021-09-10 |
| Classified | 2021-10-29 |
| Reported by FDA | 2021-11-10 |
| Distributed | 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 |
| Countries outside the US | CA |
| Quantity | 532 |
| Reason classes | sterility |
| Model numbers | 091361-01 |
Product
FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0184-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.