Karl Storz — Class II medical device recall Z-0837-2025
Ongoing recall by Karl Storz Endoscopy, reported 2025-01-22, distributed in AR, AZ, CA, CO, CT, FL, GA, HI…. Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance.
| Recall number | Z-0837-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Karl Storz Endoscopy, El Segundo, CA, United States |
| Recall initiated | 2024-12-19 |
| Classified | 2025-01-10 |
| Reported by FDA | 2025-01-22 |
| Distributed | AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OR, PA, SC, TX, VA |
| Quantity | 285 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 04048551194416 |
| Model numbers | 723400 |
Product
Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE
Reason for recall
Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0837-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.