# FDA recall Z-1531-2020

> **Karl Storz Endoscopy** · Class II · device recall initiated 2019-08-27.

## Product

Karl Storz,  Model # 11161C2, Flexible Neuroscope

## Reason for recall

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.

## Distribution

US: 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,  OUS: Canda

## Key facts

- **Recall number:** Z-1531-2020
- **Recalling firm:** Karl Storz Endoscopy
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-08-27
- **Report date:** 2020-04-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** El Segundo, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1531-2020

## Citation

> AI Analytics. FDA recall Z-1531-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1531-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*