KARL STORZ Photodynamic Diagnosis — Class II medical device recall Z-1216-2013
Terminated recall by Karl Storz Endoscopy America Inc, reported 2013-05-15, distributed nationwide. The recall was initiated because Karl Storz has confirmed that the Photodynamic Diagnosis (PDD) D-Light C Syst
| Recall number | Z-1216-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Karl Storz Endoscopy America Inc, El Segundo, CA, United States |
| Recall initiated | 2012-08-16 |
| Classified | 2013-05-08 |
| Reported by FDA | 2013-05-15 |
| Terminated | 2013-05-08 |
| Distributed | Nationwide (US) |
| Quantity | 15 units |
| Serial numbers | TX2033, TX2035, TX2036, TY2021, TY2024, TY2025, TY2026, TY2028, ZZ2007, ZZ2008, ZZ2012, ZZ2013, ZZ2016, ZZ2017, ZZ2019, ZZ2020 |
Product
KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, Instruction Manuals: PDD Telescopes, Tricam SL II, and PDD Camera Heads. Used as an optional accessory to white light cystoscopy when used in combination with the diagnostic imaging drug Cysview.
Reason for recall
The recall was initiated because Karl Storz has confirmed that the Photodynamic Diagnosis (PDD) D-Light C System instruction manuals have important safety-related changes.
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-1216-2013. 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.