Flexible Intubation Endoscopes Recalled Due to Unconfirmed Sterility
Karl Storz Endoscopy is recalling 218 units of Five S 5 3x65 flexible intubation endoscopes because sterility assurance cannot be confirmed. The affected devices were distributed worldwide including throughout the United States and Canada.
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: FDA Class II medical device with an unconfirmed sterility defect affecting a high-risk surgical application (intubation). The potential hazard—infection from non-sterile surgical instruments—is serious. No illnesses or injuries have been reported, but the defect represents a significant patient safety risk, qualifying as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Karl Storz Endoscopy is recalling Five S 5 3x65 flexible intubation endoscopes (REF: 0915612-06, sterile for single use, Rx only). A total of 218 units are affected by this recall.
The manufacturer cannot confirm that the sterility of these devices has been assured. Unsterile surgical instruments can pose a risk of infection to patients undergoing intubation procedures.
The recalled devices were distributed worldwide, including throughout the United States and Canada. The specific lots imported to the U.S. are 500472 and 500461. All lots with remaining shelf life globally are included in this recall.
Healthcare facilities and providers who have received these devices should contact Karl Storz Endoscopy for instructions regarding this recall.
The recalled product
- Product
- Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
- Manufacturer
- Karl Storz Endoscopy
- Affected units
- 218
Distribution
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