CLASS II Device recall · Reported 19 Jul 2017 · FDA Enforcement Report
Ultrasonic Endoscope recalled by Fujifilm Medical Systems U.S.A
Fujifilm Medical Systems U is recalling Ultrasonic Endoscope, distributed in Alabama, Hawaii, Missouri. The recall was initiated on 17 Feb 2017 and the FDA has classified it as Class II.
Check your package
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-2706-2017
- FDA event ID
- 76899
- Recalling firm
- Fujifilm Medical Systems U, Wayne, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Feb 2017
- FDA classified
- 10 Jul 2017
- Reported
- 19 Jul 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 17 Feb 2017 | Recall initiated by company | |
| 10 Jul 2017 | Classified by FDA | +143 days |
| 19 Jul 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Fujifilm is recalling multiple endoscopes after a retrospective review.
Product as listed by the FDA
Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripheral organs
Where it was distributed
US Distribution to : AL, HI and MO
Questions about this recall
Why was it recalled?
Fujifilm is recalling multiple endoscopes after a retrospective review.
Which lots are affected?
1U881A131 1U88A1A145 3U881A005
Where was it sold?
US Distribution to : AL, HI and MO
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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