Karl Storz Endoscopy: Device Recall

Recall Details

Recall Number

Z-0526-2025

Classification

Class II

Product Type

Device

Recalling Firm

Karl Storz Endoscopy

Status

Ongoing

Date Initiated

10/11/2024

Location

El Segundo, CA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

105 devices

Reason for Recall

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

Product Description

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

Distribution Pattern

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.

Other Recalls by Karl Storz Endoscopy

• Class II: Risk 12/19/2024
  Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
• Class II: Risk 12/19/2024
  Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
• Class II: Risk 12/19/2024
  Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
• Class II: Risk 12/19/2024
  Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
• Class II: Risk 12/19/2024
  Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

View all recalls by Karl Storz Endoscopy →