CLASS II Device recall · Reported 8 Jun 2016 · FDA Enforcement Report
Endoscope; ED-530XT Operation Manual 'Operation recalled
Fujifilm Medical Systems U is recalling Endoscope; ED-530XT Operation Manual 'Operation and Preparation' and 'Cleaning, distributed nationwide in the US. The recall was initiated on 23 Dec 2015 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-1860-2016
- FDA event ID
- 73469
- Recalling firm
- Fujifilm Medical Systems U, Wayne, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Dec 2015
- FDA classified
- 31 May 2016
- Reported
- 8 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 23 Dec 2015 | Recall initiated by company | |
| 31 May 2016 | Classified by FDA | +160 days |
| 8 Jun 2016 | 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
This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
Product as listed by the FDA
Endoscope; ED-530XT Operation Manual 'Operation and Preparation' and 'Cleaning, Disinfection and Storage'
Where it was distributed
Nationwide Distribution.
Questions about this recall
Why was it recalled?
This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
Which lots are affected?
All distribution dates :3/2003-4/2016
Where was it sold?
Nationwide Distribution.
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.
Other products in this recall event
4 other products · FDA event 73469This product is part of a recall event; the main page for the event is Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection recalled | Fujifilm Medical Systems U | Other | Nationwide | |
| CLASS II | Endoscope ED-450XL5 Operation Manual: Cleaning recalled | Fujifilm Medical Systems U | Other | Nationwide | |
| CLASS II | Endoscope ED-250XT5 Operations Manual recalled | Fujifilm Medical Systems U | Other | Nationwide | |
| CLASS II | Endoscope ED-450XT5 Operation Manual: Cleaning recalled | Fujifilm Medical Systems U | Other | Nationwide |
More recalls from Fujifilm Medical Systems U
All 37| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Synapse Cardiovascular (Synapse CV) recalled | Fujifilm Medical Systems U | Device Malfunction | Nationwide |
| Device | CLASS II | ¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit recalled | Fujifilm Medical Systems U | Device Malfunction | 6 states |
| Device | CLASS II | Synapse PACS - Radiological Image Processing System recalled | Fujifilm Medical Systems U | Device Malfunction | Nationwide |
| Device | CLASS II | Fujifilm Synapse Pacs recalled by Fujifilm Medical Systems U.S.A | Fujifilm Medical Systems U | Device Malfunction | Nationwide |
| Device | CLASS III | Wako Hdl-c/Ldl-c Calibrator recalled by Fujifilm Medical Systems U.S.A | Fujifilm Medical Systems U | Other | Nationwide |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |