Bronchovideoscope Recall for Updated Sterilization and Reprocessing Instructions
Olympus bronchovideoscopes are recalled due to updates required for proper sterilization and reprocessing procedures. Healthcare providers must follow new instructions for chemical disinfection and ETO gas sterilization.
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 a Class II FDA recall with no reported illnesses, injuries, or adverse events. The hazard is procedural (improper reprocessing and sterilization of an invasive medical device), which poses a theoretical risk to patient safety. Per the rubric, risk-of-harm products without reported injury receive a maximum score of 3.
Plain-English summary
Olympus Corporation of the Americas is recalling the BF-1TQ180 EVIS EXERA II Bronchovideoscope. All 242 units distributed nationwide in the United States are affected.
The recall addresses procedures for reprocessing and sterilization of the device. Updated instructions have been issued regarding the use of certain chemicals for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and sterilization methods.
Healthcare facilities and providers using this device should immediately review and implement the updated sterilization and reprocessing instructions provided by Olympus Corporation. Proper adherence to these procedures is essential for safe device operation.
The recalled product
- Product
- BF-1TQ180: EVIS EXERA II Bronchovideoscope
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 242
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 serial numbers. UDI: 04953170339349
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Olympus Corporation of the Americas 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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