Karl Storz RHINO-LARYNGO-BRONCHO FIBERSCOPE — Class II medical device recall Z-1532-2020
Ongoing recall by Karl Storz Endoscopy, reported 2020-04-01, distributed in AL, AZ, CA, CO, CT, DE, FL, GA…. During a complaint investigation it was determined that an error was observed within the instruction manual in
| Recall number | Z-1532-2020 |
|---|---|
| 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 | 2019-08-27 |
| Classified | 2020-03-20 |
| Reported by FDA | 2020-04-01 |
| Distributed | AL, AZ, CA, CO, CT, DE, FL, GA, IL, IN, MA, MD, MI, MN, MO, NC, NH, NJ, OH, OR, PA, SC, TN, TX, VA, WA, WI, WV |
| Quantity | 21 scopes |
| Reason classes | sterility |
| Model numbers | 11005BC1 |
Product
Karl Storz RHINO-LARYNGO-BRONCHO FIBERSCOPE, Model # 11005BC1
Reason for recall
During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) and tray information, specified for the STERIS System 1E (SS1E) sterilization method within the instruction manual is incorrect. If the user uses SS1E to sterilize the impacted scopes and referred to the manual concerning the QCK information, the sterility of reprocessed scope cannot be guaranteed.
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-1532-2020. 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.