Karl Storz Ureteroscope recalled nationwide for unapproved reprocessing instructions
Karl Storz Ureteroscope model 27000K is being recalled due to instructions for use containing reprocessing modalities not reviewed or approved by the FDA. The recall affects 82 units distributed nationwide.
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 is an FDA Class II recall where the device's instructions for use contain reprocessing modalities that lack FDA review and approval. Although no illnesses or injuries have been reported, improper sterilization could pose a risk to patient safety, meeting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Karl Storz Endoscopy is recalling 82 units of the KARL STORZ ENDOSKOPE Ureteroscope, model REF 27000K (7 Fr., 6°, 34 cm, non-sterile, RxONLY). The devices have been distributed nationwide and are identified by lot/UDI: 04048551310816.
The recall was issued because the device's Instructions for Use contain reprocessing modalities that have not been reviewed and approved by the FDA for safety and efficacy. Reprocessing instructions that lack FDA review could result in improper sterilization or disinfection of the instrument, potentially compromising patient safety.
Healthcare facilities and medical professionals in possession of this device should immediately contact Karl Storz Endoscopy for guidance on proper reprocessing procedures. Do not use the reprocessing instructions provided in the device package until corrected instructions have been supplied by the manufacturer. Facilities should document which devices they possess and verify the lot/UDI number to confirm they are affected.
The recalled product
- Product
- KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
- Manufacturer
- Karl Storz Endoscopy
- Affected units
- 82
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:04048551310816
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.
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