# FDA recall Z-2589-2023

> **Karl Storz Endoscopy** · Class II · device recall initiated 2023-07-07.

## Product

Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only

## Reason for recall

Flexible intubation endoscopes  sterility assurance can not be confirmed.

## Distribution

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, MD, ME, MEX, MI, MN, MO, MS, NC, NE, NH, NJ, 	NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, 	WV, WY and the country of  Canada.

## Key facts

- **Recall number:** Z-2589-2023
- **Recalling firm:** Karl Storz Endoscopy
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-07-07
- **Report date:** 2023-09-27

- **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-2589-2023

## Citation

> MORVS. FDA recall Z-2589-2023. Retrieved 2026-10-15 from https://api.morvs.ai/recall/Z-2589-2023. Source: US FDA. Licensed CC0.

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