FDA Device recall Z-1531-2020
Karl Storz, Model # 11161C2, Flexible Neuroscope
- FDA Device
- Class II
- ongoing
- Published 2020-04-01
On 2020-04-01 the FDA classified a Class II recall of Karl Storz, Model # 11161C2, Flexible Neuroscope by Karl Storz Endoscopy, citing during a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK)….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1531-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-08-27 |
| Published | 2020-04-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Karl Storz Endoscopy |
| Distribution | AL, AZ, CA, CO, CT, DE, FL, GA, IL, IN, MA, MD, MI, MN, MO, NC, NH, NJ, OH, OR, PA, SC, TN, TX, VA, WA, WI, WV |
Product
Karl Storz, Model # 11161C2, Flexible Neuroscope
Reason
During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) and tray information, specified for the STERIS System 1E (SS1E) sterilization method within the instruction manual is incorrect. If the user uses SS1E to sterilize the impacted scopes and referred to the manual concerning the QCK information, the sterility of reprocessed scope cannot be guaranteed.
Identifiers
| code_info | All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1531-2020%22
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