Karl Storz Endoscopy 2023-09-27 Health serious FDA
Health · FDA · Recall #FDA-Z-2589-2023
Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only Recall
Issued September 27, 2023 · Karl Storz Endoscopy
In September 2023, Karl Storz Endoscopy recalled the Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Flexible intubation endoscopes sterility assurance can not be confirmed.
What you should do
- 1 Stop using Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Karl Storz Endoscopy to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Karl Storz Endoscopy
- Category
- Health
- Recall date
- September 27, 2023
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, M
- Recall number
- FDA-Z-2589-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Karl Storz Endoscopy has 8 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.