Flexible Intubation Videoscope Recall Due to Sterility Assurance Failure
Karl Storz FIVE S 3.5x65 flexible intubation videoscopes failed sterility assurance testing. The recall affects 532 units distributed across the US and Canada due to infection risk.
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 for a medical device that failed sterility assurance testing. Although no illnesses or injuries have been reported, the defect creates a demonstrated infection risk for patients undergoing intubation procedures, meeting the threshold for a High-severity risk-of-harm product without reported injury.
Plain-English summary
Karl Storz Endoscopy is recalling 532 units of the FIVE S 3.5x65 Flexible Intubation Videoscope (models REF: 091361-01 and 091361-06). During a routine requalification review, these devices failed to meet the required sterility assurance level, meaning they may not be adequately sterilized before patient use.
The devices were distributed throughout the United States and Canada. All lot numbers with remaining shelf life are included in this recall.
Patients treated with non-sterile intubation equipment face an increased infection risk. Healthcare facilities and professionals using these devices should stop use immediately and contact Karl Storz Endoscopy for device return or replacement instructions.
No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)
- Manufacturer
- Karl Storz Endoscopy
- Affected units
- 532
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 with remaining shelf life
Distribution
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