Reported Sep 29, 2021 · Terminated
EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
Olympus Corporation of the Americas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-0610
Is this the product you have?
EVIS EXERA BF-XT160 BronchofibervideoscopeModel No. BF-XT160
- Lot codes and dates
120014825008732100707271098315003001400209260050513001631400273140024827005212500431150031012001292300805281102915002922700520210074315003132911060
- Amount recalled
- 27 globally (21 US)
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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