Olympus Endoscopic Flushing Pump
Medical device recall Z-0229-2025. Published in FDA’s Enforcement Report on Nov 6, 2024.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 6, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 445 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
445 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,993 characters
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 22331156 22331341 22331342 22331362 22331343 22331155 22331172 22326893 22331152 22331904 22331903 22331458 22331556 22331561 22331546 22331558 22331461 22331460 22331459 22331457 22331477 22331345 22331557 22331756 22331760 22331559 22331560 22331759 22331758 22331851 22331849 22331846 22331845 22331847 22331848 22331786 22331755 22332160 22332318 22332283 22332484 22332187 22332284 22332316 22332483 22332346 22332321 22332320 22332159 22332285 22332185 22332184 22332186 22332161 22332158 22332156 22332188 22332488 22332486 22332490 22332489 22332345 22332317 22332183 22332312 22332281 22332060 22332035 22332036 22332059 22332709 22331932 22332718 22332061 22331908 22332861 22332032 22332624 22333316 22333194 22333301 22333433 22333200 22333300 22333296 22333177 22333432 22333429 22333434 22333298 22333318 22333299 22333315 22333430 22333319 22333435 22333431 22333428 22333201 22333175 22332981 22332980 22332860 22332869 22332957 22332951 22332870 22332863 22332949 22332954 22332956…
FDA’s list runs to 4,044 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Aug 23, 2024.
- FDA classified it on Oct 25, 2024.
- FDA’s Enforcement Report published it on Nov 6, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Olympus Corporation of the Americas, of Center Valley, PA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 4,044 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.