FDA Device recall Z-0229-2025
Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
- FDA Device
- Class II
- ongoing
- Published 2024-11-06
On 2024-11-06 the FDA classified a Class II recall of Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141) by Olympus, citing during product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0229-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-23 |
| Published | 2024-11-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Olympus |
| Distribution | US |
Product
Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
Reason
During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure.
Identifiers
| code_info | UDI-DI: 15019778003191; Serial Numbers: 22324681 22324838 22324815 22324817 22324668 22324816 22324667 22324666 2232483…UDI-DI: 15019778003191; Serial Numbers: 22324681 22324838 22324815 22324817 22324668 22324816 22324667 22324666 22324837 22325205 22325319 22325320 22325005 22324922 22325318 22325008 22324932 22325207 22324931 22325306 22325593 22325317 22325208 22325315 22325316 22325409 22325411 22325305 22325304 22325408 22325410 22324923 22325303 22325592 22325579 22326433 22325665 22326420 22326435 22326299 22325582 22325594 22326281 22324536 22326418 22326419 22325580 22325595 22325651 22326417 22325650 22326434 22326436 22325649 22326495 22325581 22326284 22326283 22325583 22326309 22326308 22326282 22326892 22326891 22326503 22326599 22326895 22326597 22326897 22326608 22326506 22326894 22326598 22326496 22327325 22327322 22326607 22326497 22327327 22326600 22327323 22326505 22329514 22329504 22329332 22329506 22329503 22329507 22329497 22329467 22329513 22329341 22329343 22329331 22329751 22329596 22329752 22329605 22329608 22329753 22329610 22331369 22331173 22331037 22331153 22331035 223311 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0229-2025%22
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