Recall Z-0229-2025 ยท FEQ Pump, Air, Non-Manual, For Endoscope
Olympus Corporation of the Americas
Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
| Date | Oct 25, 2024 (initiated Aug 23, 2024) |
| Status | Open, Classified |
| Reason | During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure. |
| Root cause | Equipment maintenance |
| Action | An URGENT: MEDICAL DEVICE CORRECTION notification letter dated 9/20/24 was sent to customers. Actions Required: Our records indicate that your facility has purchased one or more of the affected products. The range of affected serial numbers is included at the top of this letter. The serial number is on a label affixed to the back of the OFP-2 pump. An Olympus representative will create a Return Material Authorization for the return of your device to Olympus for an inspection. You may continue to use your OFP-2 pump until an Olympus representative performs the inspection. If the OFP-2 fails t |
| Quantity | 445 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100899 | OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2 Keymed (Medical & Industrial Equipment), Ltd., Sep 13, 2010 |