# FDA recall Z-0526-2025

> **Karl Storz Endoscopy** · Class II · device recall initiated 2024-10-11.

## Product

4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x    3.5 x 70 mm REF 28206CBS Full Radius Resector, sterile, 6x    5.5 x 120 mm REF 28205NDS Aggr. Pro Line Shaver Blade, sterile, 6x    5.5 x 120 mm REF 20205FDS Round Burr, sterile, 6x    6.5 x 120 mm REF 28205HES, Aggressive Barrel Burr, sterile, 6x    4.2 x 120 mm REF 28205GDS Finish Barrel Burr, sterile, 6x    5.5 x 180 mm REF 28208IDS Semi Hooded Barrel Burr, sterile, 6x    5.5 x 120 mm REF 28205HDS Aggressive Barrel Burr, sterile, 6x

## Reason for recall

Due to holes detected in the inner barrier system that may compromise the sterility of the affected products.

## Distribution

Worldwide - U.S. Nationwide distribution in the states of AL, FL, IA, IN, KS, MA, MO, MT, NJ, NY, OH, PA, TX, TN, and VA. The countries of Canada and Germany.

## Key facts

- **Recall number:** Z-0526-2025
- **Recalling firm:** Karl Storz Endoscopy
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-11
- **Report date:** 2024-12-04

- **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-0526-2025

## Citation

> AI Analytics. FDA recall Z-0526-2025. Retrieved 2026-08-12 from https://api.ai-analytics.org/recall/Z-0526-2025. Source: US FDA. Licensed CC0.

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