# FDA recall Z-1981-2023

> **Karl Storz Endoscopy** · Class II · device recall initiated 2023-04-05.

## Product

KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A

## Reason for recall

Plastic sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time specific to the tray models, that also includes information regarding the sterilization modality.

## Distribution

Worldwide - US Nationwide distribution including in the states of AK, AR, AZ, CA, CT, DC,  DE, FL, GA, HI, IL, IN, KS, LA, MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OR, PA, RI,  SC, VA, VT, AL, CO, GU, IA, ID, KY, ME, MN, MT, ND, NE, NJ, NM, OK, PR, SD, TN, UT, WA, WI, WV, WY and the country of CA.

## Key facts

- **Recall number:** Z-1981-2023
- **Recalling firm:** Karl Storz Endoscopy
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-04-05
- **Report date:** 2023-06-28

- **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-1981-2023

## Citation

> AI Analytics. FDA recall Z-1981-2023. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-1981-2023. Source: US FDA. Licensed CC0.

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