Recall Z-2589-2023— Karl Storz Endoscopy

Name: FDA recall Z-2589-2023
Creator: U.S. Food and Drug Administration
Published: 2023-07-07

Class II · Ongoing

Class II FDA medical device recall by Karl Storz Endoscopy, initiated 2023-07-07. It names one FDA 510(k) clearance: K212656. Product: Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only. Reason: Flexible intubation endoscopes sterility assurance can not be confirmed..

Recalling firm: Karl Storz Endoscopy
Classification: Class II
Status: Ongoing
Initiated: 2023-07-07
Firm location: El Segundo, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K212656 — Flexible Intubation Video Endoscope Sterile (FIVE-S)Karl Storz Endoscopy America·cleared 2021-12-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Flexible intubation endoscopes sterility assurance can not be confirmed.

Data sourced from openFDA. This site is unofficial and independent of the FDA.