Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0184-2022 — FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)

U.S. FDA — Device Enforcement · United States · 2021-09-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0184-2022
Date of alert
2021-09-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Karl Storz Endoscopy
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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