Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
FIVE S 3.5x65 Recalled by Karl Storz Endoscopy Due to During a regular requalification review, affected flexible intubation...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Karl Storz Endoscopy directly.
Affected Products
FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)
Quantity: 532
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 40 states: AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NV, NH, NJ, NM, NY, NC, OH, OR, PA, SC, TN, TX, UT, VT, VA, WA, WV, WI, DC
About Karl Storz Endoscopy
Karl Storz Endoscopy has 70 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report