Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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 22333067 22333088 22333089 22333066 22333064 22332868 22333180 22410039 22410042 22410036 22410038 22410041 22410217 22410218 22410040 22410216 22410215 22410214 22410220 22410213 22410037 22333603 22333599 22333605 22333297 22331850 22333602 22333179 22333601 22333604 22333195 22333606 22410904 22410474 22410725 22410723 22410727 22410724 22410726 22410835 22410833 22410446 22410545 22410544 22410704 22410834 22410840 22410838 22411043 22410473 22410542 22410476 22410543 22410445 22410540 22410538 22331757 22410541 22410706 22410702 22410477 22410705 22410475 22410448 22410539 22410384 22410354 22410355 22410444 22410352 22410478 22410351 22410356 22332622 22332621 22332286 22332287 22411047 22410836 22411771 22411045 22411046 22411790 22411773 22411772 22411770 22410992 22411044 22412004 22411953 22412266 22412293 22412292 22412099 22412283 22412294 22412097 22412281 22412268 22412267 22412098 22412291 22412111 22412282 22412100 22412269 22411860 22412005 22412110 22411861 22411951 22412002 22412003 22411863 22412102 22412357 22412356 22412354 22412381 22412355 22412353 22412382 22412380 22412461 22412573 22412571 22412490 22412583 22412557 22412585 22412584 22412462 22412822 22412487 22412488 22412587 22412586 22412489 22412556 22412554 22412492 22412553 22412486 22412480 22412481 22412485 22412484 22412821 22412850 22412849 22412459 22412458 22412460 22412823 22412847 22412824 22412825 22413151 22412972 22413167 22412971 22412969 22412974 22412968 22413169 22413145 22412962 22412944 22412970 22412965 22413168 22412964 22412963 22413166 22412946 22413171 22413173 22413147 22413174 22412967 22413149 22413179 22412966 22412943 22413146 22413150 22412846 22412911 22412928 22412912 22412265 22412975 22412907 22412941 22412930 22412935 22412909 22412908 22412932 22412933 22412910 22413255 22413148 22413259 22413258 22413175 22413177 22413170 22413873 22413814 22413929 22413812 22413813 22413767 22413774 22413523 22413743 22413775 22413757 22413520 22413385 22413386 22413529 22413758 22413760 22413741 22413773 22413771
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Olympus Corporation of the Americas
- Reason for Recall:
- During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
Product Codes/Lot Numbers:
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 22333067 22333088 22333089 22333066 22333064 22332868 22333180 22410039 22410042 22410036 22410038 22410041 22410217 22410218 22410040 22410216 22410215 22410214 22410220 22410213 22410037 22333603 22333599 22333605 22333297 22331850 22333602 22333179 22333601 22333604 22333195 22333606 22410904 22410474 22410725 22410723 22410727 22410724 22410726 22410835 22410833 22410446 22410545 22410544 22410704 22410834 22410840 22410838 22411043 22410473 22410542 22410476 22410543 22410445 22410540 22410538 22331757 22410541 22410706 22410702 22410477 22410705 22410475 22410448 22410539 22410384 22410354 22410355 22410444 22410352 22410478 22410351 22410356 22332622 22332621 22332286 22332287 22411047 22410836 22411771 22411045 22411046 22411790 22411773 22411772 22411770 22410992 22411044 22412004 22411953 22412266 22412293 22412292 22412099 22412283 22412294 22412097 22412281 22412268 22412267 22412098 22412291 22412111 22412282 22412100 22412269 22411860 22412005 22412110 22411861 22411951 22412002 22412003 22411863 22412102 22412357 22412356 22412354 22412381 22412355 22412353 22412382 22412380 22412461 22412573 22412571 22412490 22412583 22412557 22412585 22412584 22412462 22412822 22412487 22412488 22412587 22412586 22412489 22412556 22412554 22412492 22412553 22412486 22412480 22412481 22412485 22412484 22412821 22412850 22412849 22412459 22412458 22412460 22412823 22412847 22412824 22412825 22413151 22412972 22413167 22412971 22412969 22412974 22412968 22413169 22413145 22412962 22412944 22412970 22412965 22413168 22412964 22412963 22413166 22412946 22413171 22413173 22413147 22413174 22412967 22413149 22413179 22412966 22412943 22413146 22413150 22412846 22412911 22412928 22412912 22412265 22412975 22412907 22412941 22412930 22412935 22412909 22412908 22412932 22412933 22412910 22413255 22413148 22413259 22413258 22413175 22413177 22413170 22413873 22413814 22413929 22413812 22413813 22413767 22413774 22413523 22413743 22413775 22413757 22413520 22413385 22413386 22413529 22413758 22413760 22413741 22413773 22413771
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0229-2025
Related Recalls
Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to deliver a nylon loop snare.
Olympus Corporation of the Americas
Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.
Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users.
Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815). All other components in the kits were correctly included and packaged in the kit.