Karl Storz Uretero-Renoscope recalled for unapproved reprocessing instructions
Karl Storz Endoscopy has recalled the KARL STORZ ENDOSKOPE Uretero-Renoscope nationwide because its instructions for use contain reprocessing procedures that lack FDA review and approval for safety and efficacy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard involves unapproved reprocessing instructions that could result in improper sterilization, presenting a theoretical risk of infection. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Karl Storz Endoscopy has recalled the KARL STORZ ENDOSKOPE Uretero-Renoscope (Reference 27010L, 7 French, 43 cm, Non-Sterile) nationwide. Approximately 1,510 units with UDI 04048551231333 are affected by this recall.
The recall was issued because the device's instructions for use contain reprocessing modalities that have not been reviewed and/or approved by the FDA for safety and efficacy. Proper reprocessing and sterilization are critical to ensuring the device is safe for use in clinical procedures.
This device is distributed to healthcare facilities across the United States.
Healthcare providers using this device should contact Karl Storz Endoscopy for corrected reprocessing instructions and guidance regarding the safe use of affected units.
The recalled product
- Product
- KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123
- Manufacturer
- Karl Storz Endoscopy
- Hazard
- improper-sterilization
- infection-risk
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 (1)
- All Lots/UDI: 04048551231333
Distribution
Distributed nationwide across the United States.
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