Karl Storz Uretero-Renoscope with Unapproved Reprocessing Instructions Recalled
Karl Storz Endoscopy is recalling 59 units of its uretero-renoscope due to instructions for use containing reprocessing procedures that the FDA has not reviewed or approved for safety and efficacy.
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 3/5 (High).
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 FDA Class II medical device recall involves instructions containing reprocessing procedures not reviewed or approved by the FDA. No illnesses or injuries have been reported. This meets the rubric criterion for a High severity rating as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Karl Storz Endoscopy is recalling 59 units of the KARL STORZ ENDOSKOPE Uretero-Renoscope (REF: 27001L, 8 Fr., 43 cm, non-sterile) with UDI 04048551231210. The recall affects units distributed nationwide in the United States.
The device's instructions for use contain reprocessing methods that have not been reviewed or approved by the FDA for safety and efficacy. Proper reprocessing and sterilization are essential to ensure the device is safe for use in clinical procedures.
Healthcare facilities and providers who have received this device should verify that any reprocessing procedures comply with FDA-approved sterilization standards. Do not use the reprocessing procedures described in the device instructions. Contact Karl Storz Endoscopy for updated instructions that comply with FDA requirements.
The recalled product
- Product
- KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
- Manufacturer
- Karl Storz Endoscopy
- Affected units
- 59
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: 04048551231210
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 14 recalled by Karl Storz Endoscopy under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 14 products in this recall →Related recalls
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