Flexible DCI Intubation Fiberscope — Class II medical device recall Z-2894-2020
Ongoing recall by Karl Storz Endoscopy, reported 2020-09-02, distributed nationwide. Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used,
| Recall number | Z-2894-2020 |
|---|---|
| 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 | 2020-07-27 |
| Classified | 2020-08-27 |
| Reported by FDA | 2020-09-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 463 |
| Reason classes | chemical contamination |
| Model numbers | 11301BND1 |
Product
Flexible DCI Intubation Fiberscope, Part: 11301BND1, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
Reason for recall
Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible intubation endoscopes with total lumen lengths greater than 850mm. Incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in infection.
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-2894-2020. 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.