FDA Device recall Z-0138-2017
OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector
- FDA Device
- Class II
- terminated
- Published 2016-10-26
On 2016-10-26 the FDA classified a Class II recall of OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector by Olympus, citing new warning requiring Users to conduct duodenoscope precleaning and manual cleaning even when using an Automated Endoscope Reprocessor (AER) that has instructions that may indicat….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0138-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-23 |
| Published | 2016-10-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Olympus |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY |
Product
OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector
Reason
New warning requiring Users to conduct duodenoscope precleaning and manual cleaning even when using an Automated Endoscope Reprocessor (AER) that has instructions that may indicate a user could forego certain steps in precleaning and manual cleaning of the endoscopes.
Identifiers
| code_info | Model: OER-Pro, All serial numbers affected |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0138-2017%22
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