11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016);
Summary
The FDA issued a Class II for 11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flex by Karl Storz Endoscopy. Reason: Failure to achieve the expected six-log reduction in microorganisms following the disinfection process..
Details
Source
Device Recall
External ID
Z-1067-2022
Action Date
2022-05-18
Status
Ongoing
Category
device
Product Description
11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016); 11278AC2 11278ACK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278ACU1 11278ACUK1 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AU1 11278AUK1 Flexible Ureteroscope Z20615US-BA (08-2018);
Lot/Code Info: 11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018) UDI Code: 4048551402573; 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016) UDI Code: 4048551226353; 11278AC2 11278ACK2 Flexible Ureteroscope Z20615US-BA (08-2018) UDI Code: 4048551402504; 11278ACU1 11278ACUK1 Flexible Ureteroscope Z20615US-BA (08-2018) UDI Code: 4048551226377; 11278AU1 11278AUK1 Flexible Ureteroscope Z20615US-BA (08-2018) UDI Code: 4048551226438; All Serial Numbers manufactured/distributed since January 2018.
Quantity Affected: All Serial Numbers manufactured/distributed since January 2018.
Reason for Recall
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Distribution
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, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA,WI, WV, and WY. O.U.S.: Mexico, Lebanon, and South Korea
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-01
Company
El Segundo, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 140 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Karl Storz Endoscopy has 52 FDA actions in our database, including 52 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Karl Storz Endoscopy) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Karl Storz Endoscopy have FDA actions?
Karl Storz Endoscopy has 52 FDA actions in our database, including 52 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1067-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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