CLASS II Device recall · Reported 29 Sep 2021 · FDA Enforcement Report

Evis Exera Bf-XT160 Bronchofibervideoscope recalled

Olympus Corporation of the Americas is recalling Evis Exera Bf-XT160 Bronchofibervideoscope, distributed nationwide in the US. The recall was initiated on 17 Aug 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1200148 2500873 2100707 2710983 1500300 1400209 2600505 1300163 1400273 1400248 2700521 2500431 1500310 1200129 2300805 2811029 1500292 2700520 2100743 1500313 2911060

Quantity recalled27 globally (21 US)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2497-2021
FDA event ID: 88560
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Terminated
Recall initiated: 17 Aug 2021
FDA classified: 21 Sep 2021
Reported: 29 Sep 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

17 Aug 2021	Recall initiated by company
21 Sep 2021	Classified by FDA	+35 days
29 Sep 2021	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160

Where it was distributed

US Nationwide distribution in the states of CA, IL, MA, MD, MI, NY, OH, OR, and PA.

Nationwide California Illinois Massachusetts Maryland Michigan New York Ohio Oregon Pennsylvania

Questions about this recall

Why was it 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.

Which lots are affected?

1200148 2500873 2100707 2710983 1500300 1400209 2600505 1300163 1400273 1400248 2700521 2500431 1500310 1200129 2300805 2811029 1500292 2700520 2100743 1500313 2911060

Where was it sold?

US Nationwide distribution in the states of CA, IL, MA, MD, MI, NY, OH, OR, and PA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Olympus Corporation of the Americas

All 415

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Powerseal (in diameter) (long), Curved Jaw Sealer & Divider recalled	Olympus Corporation of the Americas	Labeling Errors	Nationwide
29 Jul 2026Device	CLASS II	Olympus 4K UHD LCD Monitor recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Other	Nationwide
29 Jul 2026Device	CLASS II	Olympus High Flow Insufflation Unit - UHI recalled	Olympus Corporation of the Americas	Other	Nationwide
22 Jul 2026Device	CLASS II	Olympus Toomey Evacuator 50cc with Adaptor recalled	Olympus Corporation of the Americas	Sterility	Nationwide
22 Jul 2026Device	CLASS II	Olympus Glass Body for 194 Ellik Evacuator recalled	Olympus Corporation of the Americas	Foreign Material	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide