Karl Storz Endoscopy 2022-05-18 Health serious FDA
Health · FDA · Recall #FDA-Z-1067-2022
11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible… Recall
Issued May 18, 2022 · Karl Storz Endoscopy
In May 2022, Karl Storz Endoscopy recalled the 11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
What you should do
- 1 Stop using 11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible… 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
- May 18, 2022
- Units affected
- Not reported
- Sold at
- U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ,
- Recall number
- FDA-Z-1067-2022
- 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 870th Health recall we've logged in 2022.