EVIS EXERA BF-XT160 Bronchofibervideoscope recall
EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
Why was EVIS EXERA BF-XT160 Bronchofibervideoscope recalled?
A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection control risk.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
1200148 2500873 2100707 2710983 1500300 1400209 2600505 1300163 1400273 1400248 2700521 2500431 1500310 1200129 2300805 2811029 1500292 2700520 2100743 1500313 2911060
- Product
- EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 27 globally (21 US)
- Distribution
- US Nationwide distribution in the states of CA, IL, MA, MD, MI, NY, OH, OR, and PA.
- Recall date
- September 29, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)