Karl Storz Recalls Photodynamic Diagnosis Instruction Manuals for Safety Updates
Karl Storz is recalling 15 units of PDD D-Light C System instruction manuals because they contain important safety-related changes.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations, indicating a precautionary update to documentation rather than a direct physical hazard.
Plain-English summary
Karl Storz Endoscopy America Inc is recalling 15 units of instruction manuals for the Photodynamic Diagnosis (PDD) D-Light C System. The recall covers manuals for PDD Telescopes, Tricam SL II, and PDD Camera Heads, which are used as optional accessories to white light cystoscopy in combination with the diagnostic imaging drug Cysview.
The recall was initiated because Karl Storz confirmed that the instruction manuals have important safety-related changes. The affected units were distributed nationwide in the United States, including Illinois, California, West Virginia, Texas, South Carolina, Wisconsin, New York, Pennsylvania, Nebraska, New Jersey, Maryland, Ohio, Iowa, and North Carolina.
The specific serial numbers for the recalled manuals are ZZ2008, ZZ2016, ZZ2012, ZZ2019, TY2024, ZZ2013, TY2026, TY2025, TY2028, TY2021, ZZ2007, ZZ2020, TX2036, TX2033, ZZ2017, and TX2035. Users should contact Karl Storz Endoscopy America Inc for further instructions regarding the updated safety information.
The recalled product
- 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.
- Manufacturer
- Karl Storz Endoscopy America Inc
- Hazard
- Affected units
- 15
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- The device Instruction Manual recall
- which includes: 1) Telescope
- 2) Camera Head
- and TX2035.
Distribution
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